MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PORT & CATHETER, IMPLANTED

Catalog Number	H965440140
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the device from the reported event will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, a bioflo port which had been placed in (b)(6) 2016 was removed on (b)(6) 2019 because "a crack in the port body was causing extravasation of infusates into the port pocket." it was indicated that the used port would be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records 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 recent angiodynamics vascular access complaint report was reviewed for the bioflo port product family and the failure mode "device leaked." no adverse trend was identified.The port was returned with a small piece of catheter tubing attached.The septum showed evidence of multiple use and damage.Damage was also noted to the port body.The end user's complaint description is confirmed for leakage.The leakage from the port was coming from damage to the port septum.The likely root cause of the damage to the port septum is from coring caused by a damaged needle or by someone not using a non-coring needle to access the port.The was also damage observed to the port body where a needle missed the mark on the septum and scratched the side of the port housing.No manufacturing related non-conformance was observed during sample evaluation.This is supported by the fact that the device was implanted and in use for more than 31 months prior to the leak incident.The directions for use packaged with the bioflo port contains the following precautions: precautions only use non-coring needles to access the port membrane.The non-coring needle tip is integral to prevent damage of the membrane.· palpate the port and port septum then access the silicone membrane with the non-coring needle at a 90 degree angle.· puncture skin directly over septum and gently advance needle through septum until it contacts bottom of portal chamber.Do not apply excessive force once the needle contacts the port floor.This is the only reported complaint for this failure mode in the past 15 months for the bioflo port product family, as such, this is deemed to be an isolated incident.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8548958
• Report Number: 1317056-2019-00059
• Device Sequence Number: 16754957
• Product Code: LJT
• UDI-Device Identifier: H965440140
• UDI-Public: H965440140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965440140
• Device Lot Number: 5046470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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