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

Catalog Number	H965458110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
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 trend was identified.Received 1 used picc line.The reported complaint description is confirmed for hole in catheter tubing near suture wing.No manufacturing non-conformance was observed during sample evaluation.Id and od measurements of catheter tubing were taken near the hole (proximal body end of catheter) and they met specification.Hole is likely a fatigue flexural failure due to catheter tubing being repeatedly kinked.All piccs are 100% air leak tested during production so a hole in the catheter tubing would be identified during this inspection.Securing the picc suture wing too close to the exit site likely resulted in the catheter tubing being kinked.Hole in catheter is related to handling damage of the device during use.
Event or Problem Description
As reported by angiodynamics' distributor in the uk, a picc device fractured at the suture wing location.It was originally stated that the fracture occurred during the implantation procedure, however, examination of the condition of the returned sample on (b)(6) showed that it had been implanted for a length of time, thus needed to be removed and replaced.No patient injury or complications were reported.

• 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: 8704891
• Report Number: 1317056-2019-00076
• Device Sequence Number: 19288080
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 12/31/2019
• Device Catalogue Number: H965458110
• Device Lot Number: 5281863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1