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

Catalog Number	H965750171
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics, however, the evaluation is still in process.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, an indwelling picc was removed due to "leakage above the white hub at the area of the tubing connection." the patient condition was listed as "unaffected," and the catheter was not replaced.The used device has been returned to angiodynamics.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the indicated packaging and picc assembly 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 january 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "oversleeve - extension tubing/hole fracture." no adverse trend was identified.The returned catheter was visually inspected and a small pinch mark in the tubing at the junction with the oversleeve (which could have occurred during the molding process) was noted.The pinch likely propagated over time and caused the tubing to eventually fail.The fact that the picc was inserted on (b)(6) 2016 but failed only on (b)(6) 2016 supports that the product failed over time.No other manufacturing or design related non-conformances were observed during the sample evaluation.This event is deemed to be an isolated incident and no correction is required.Based on the low frequency, no adverse trends, no issues noted in the dhr, and adequate process controls in place, no corrective action to be taken at this time.Angiodynamics' manufacturing process controls for the bioflo picc, prior to molding the oversleeve to the tubing, 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.An end-of-lot visual inspection based on an aql is performed for molding defects that includes but is not limited to visualizing for over melts, flash, blow-bys, short-shots, pinch marks and verifying product was molded per the drawing.Additionally, various dimensional verifications and a tensile test of the extension tube to overmolded sleeve based on an aql are performed.Finally, 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 was deemed these process controls adequate to address this failure mode.(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: 5901005
• Report Number: 1317056-2016-00133
• Device Sequence Number: 10966408
• Product Code: LJS
• UDI-Device Identifier: H965750171
• UDI-Public: H965750171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 07/31/2017
• Device Catalogue Number: H965750171
• Device Lot Number: 4915192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR