MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / XCELA; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	M001456720
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device from the reported event has been returned to angiodynamics, however the investigation has not yet been completed.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, following placement of an xcela picc device, the catheter had to be removed and replaced because of a leak.The used catheter has been returned to angiodynamics for evaluation.No patient injury or complications were reported.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The june 2019 angiodynamics complaint report was reviewed for the xcela picc product family and the failure mode "hub detached/separated/fractured." no adverse trends were identified.The reported complaint description is confirmed; the hub luer was detached from the extension tubing on the returned device sample.Engineering evaluation was performed and the root cause of the leak is that the hybrid luer was not inserted fully into the oversleeve/extension tube during the assembly process.During manufacturing the hybrid luer is partially inserted in the oversleeve, adhesive applied and then it is fully inserted.After investigating it was determined the root cause was operator error.During the bonding process per manufacturing procedure, the operator failed to verify the luer was fully seated in the oversleeve.The non-conformance was inadvertently missed during the 100% visualization per their procedure.The operators who performed the applicable work step on the catheters that were assembled for the identified work orders have been retrained on the procedure.

• Brand Name: ANGIODYNAMICS / XCELA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8682330
• Report Number: 1317056-2019-00073
• Device Sequence Number: 2103067
• Product Code: LJS
• UDI-Device Identifier: M001456720
• UDI-Public: M001456720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: M001456720
• Device Lot Number: 5416549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1