The distributor in (b)(6) reported that during receiving and inspection of incoming products, "creases" were found in the sealing area of the sterile packages containing the flovac suction/irrigation hand piece with 10' preattached tubing, dual spikes and sump cannula.Testing result confirmed that the returned package failed the dye leak test on (b)(6) 2015.There was no patient involvement with this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.
|
Conmed corporation received two (2) "unopened" packages containing the flovac suction/irrigation hand piece with 10' preattached tubing, dual spikes and sump cannula for evaluation.Visual examination of the returned products found the packages with small creases in the sealing areas on the straight seals of the packages (seal opposite chevron seal).It appears that there may be small channels through the entire seal.These devices were transferred to packaging engineering test lab for dye leak testing and were confirmed as both devices failed the leak test on (b)(6) 2015, resulting in a breach of sterility.The lot was manufactured on 30-sep-2014.A review of the device history record for this lot found no ncrs and no noted discrepancies during the manufacturing process.In this instance, preliminary investigation revealed that the most probable cause of the creases found in the seals is due to inadequate placement of the device onto the bar sealer that is most likely related to operator error, or, the pouch packaging was damaged prior to sealing and was missed on inspection.The entire lot consisting of two hundred fifty (250) units was shipped to the distributor who found only two (2) units with creases in the seals.This distributor performs 100% incoming inspection of all devices.A two year review of product history for this device family showed other than this complaint there have been seven (7) additional reports received regarding creases in the sterile seals.During this same two year time frame, over 149,375 units were sold worldwide, making the occurrence rate for this reported failure mode 0.005 percent.The reported packaging anomalies were obvious to the distributor and therefore prompted the return of the device for evaluation and replacement.To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation has been initiated to address this issue.As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use).In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
|