Tubing Set Distributor Warned Over Design Changes, Complaint Handling

Topspins, a specification developer and own-label distributor of IV tubing sets, was warned by the U.S. FDA after making design changes without appropriate validation.

The Ann Arbor, Mich., company made several changes to its Smart Set tubing, including switching from a needle-based to needleless sideport and elimination of a sideport, according to the Nov. 6 letter posted online.

But the company had no raw data showing that it performed design verification studies, the letter says. It also lacked documentation supporting the decision to substitute verification for design validation.

Neither of Topspins’ design control procedures included important requirements for design validation, such as design risk analysis, that devices conform to user needs and intended uses, and that operating conditions on initial production units, lots or batches are defined.

The investigator also cited the company for not documenting its decision on whether to investigate a complaint on “No Phase Wrap.” According to the complaint, flame and smoke were visible from the sleeves on the patient’s arms where the wraps were worn.

Meanwhile, on March 26, 2014, the company received Smart Set tubing sets that were out of specification, but no evaluation of the need for an investigation was documented. Topspins also lacked a documented signature of the president authorizing use of the devices “as is.”

Topspins’ procedure for receiving a shipment requires a certain measurement of the incoming Smart Set tubing set received from a supplier. However, the company had no documented specifications for one version of the Smart Set tubing.

The firm inspected random samples from different boxes of Smart Set tubing for certain versions received on March 26, but its procedures didn’t include a statistical rationale for the number of boxes inspected for incoming lots, the letter says.

Topspins’ corrective and preventive action procedure was also deficient as it lacked requirements for verification and validation and for implementing and recording changes in methods and procedures. The warning letter followed an Aug. 5-15, 2014, inspection by the Detroit district office.

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