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

Catalog Number	H965458940
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
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 s 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.As received, the returned catheter contained bio material {blood} and a hole was noted in the catheter tubing just distal to the suture wing.The hole is a cut from the outside of the catheter toward the center of the catheter.The root cause of the hole in the catheter is likely due to something sharp (such as a scalpel) cutting half way through the catheter just below the suture wing.Angiodynamics' manufacturing process controls for the bioflo picc include a visual inspection for foreign matter and damaged tubing.Additionally, a 100% in process visual inspection that includes, but is not limited to visualizing for bent hub at tubing point, short shots, sink marks, flash, and splay is required.A 100% in process visual inspection for molding defects and a guidewire insertion test to verify lumen patency is also required.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.A sprint air/burst test for leakage and a fluid burst test based on an aql are also performed.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), an indwelling picc was removed and replace due to a hole located distal to the suture wing.No patient injury was reported.The used device has been returned to angiodynamics for evaluation.

• 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: 7446238
• Report Number: 1317056-2018-00045
• Device Sequence Number: 2211154
• Product Code: LJS
• UDI-Device Identifier: H965458940
• UDI-Public: H965458940
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: H965458940
• Device Lot Number: 5286558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention