Device #1.As reported: (b)(6) said the catheter was leaking under the hub.Two devices had the same issue, both had the same lot number and upn number.Both were used on the same patient.Both catheters were replaced, the second defective catheter was replaced with a 24cm rather than a 20cm.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
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As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.A photo of the cracked hub was provided for evaluation.The customer's reported complaint description cannot be confirmed due to the sample not being returned although a photo was provided.A definitive root cause for the hub crack cannot be determined.Angiodynamics' supplier of this device was notified of the event.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use (ic 147), which is supplied to the end user with states; "it is recommended that only luer lock (threaded) connections be used with this catheter (including syringes, bloodlines, iv tubing and injection caps).Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.Inspect the catheter frequently for nicks, scrapes, cuts, etc.Which could impair it performance." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
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