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

Catalog Number	H965458890
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the device from the reported event will be returned to angiodynamics for evaluation, it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, a bioflo picc which had been inserted on (b)(6) 2017 was removed on (b)(6) 2018 due to fluid leaking when the catheter was flushed.Upon removal, a hole at the junction of the picc and the suture wing was noted.It has been indicated that the used catheter will be returned to angiodynamics for evaluation.
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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter - hole distal to suture wing." no adverse trends were identified.The reported complaint description of a hole in the catheter is confirmed, as there is a hole in the catheter just distal to the suture wing.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.Although no definitive root cause could be determined from sample review, it is unlikely that the hole is a result of the device manufacturing as it was placed and in use for several months prior to the reported event.In addition, it is unlikely that this defect occurred at angiodynamics as minimal processing is performed on catheter prior to placing in tray for packaging.Manufacturing process controls for the bioflo picc devices include a 100% a visual inspection for molding defects and a guidewire insertion test to verify lumen patency.The guidewire must pass through the catheter with little to no resistance to be considered acceptable.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7388017
• Report Number: 1317056-2018-00035
• Device Sequence Number: 196121
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: Nurse
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H965458890
• Device Lot Number: 5238190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1