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

Catalog Number	H96560M0224741
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics.A device evaluation is currently in progress.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, a picc was placed bedside.After placement it was flushed and saline was noted to be leaking out of the catheter near the hub.The catheter was removed and replaced.There was no patient injury or complications.The used device has been 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 for the bioflo picc product family and the failure mode "catheter - hole distal to suture wing." no adverse trend was identified.As received, the returned catheter contained a slit in the catheter distal to the suture wing.This condition would have resulted in the reported leakage.The slit is between the 3-4 cm mark and is approximately 1/2 cm long.Except for the slit, the catheter was found to be normal in appearance and the od measured within specification.Although a definitive root cause cannot be determined, the cut does not appear to have been the result of a manufacturing non-conformance.A potential root cause for cut in the catheter tubing is damage from a scalpel during placement procedure.Angiodynamics' manufacturing process controls for this catheter includes various dimensional verifications and a tensile test of the extension tube to overmolded sleeve based on an aql.A 100% in process visual inspection for molding defects and a guidewire insertion test to verify lumen patency is required.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.At this time, angiodynamics has deemed these process controls adequate to address this failure mode.The directions for use packaged with the picc contains the warning, "do not use sharp insturments near the extension tubes or catheter shaft." (pr19079).

• Brand Name: ANGIODYNAMICS / BIOFLO PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7454563
• Report Number: 1317056-2018-00049
• Device Sequence Number: 1575518
• Product Code: LJS
• UDI-Device Identifier: H96560M0224741
• UDI-Public: H96560M0224741
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/10/2018

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: H96560M0224741
• Device Lot Number: 5257107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1