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

Catalog Number	H965750171
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used catheter from the reported event has been returned to angiodynamics, however the device evaluation is not yet completed.Upon conclusion of the investigation a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
Per event report, : "the patient arrived for infusion services with a bioflo 4 french, single lumen picc.Upon initiating aspiration for labs, the hub physically detached from the catheter.The nurse used a clamp on the catheter to help stop bleeding.The nurse then removed the picc line and replaced it with a new bioflo 4 french single lumen picc line.The new line functioned properly and therapy was able to be completed.There was no patient injury and the patient's status is fine.The used catheter has been returned to angiodynamics.
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 august 2019 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "hub extension tubing cracked/detached." no adverse trend was indicated.In addition, this is the only reported complaint for this failure mode in the past 15 months for the bioflo picc product family.As received, the purple valve on the catheter was detached for the oversleeve.The barbed section contained adhesive around the barbed section of the valve.The end user's reported complaint description is confirmed.The most likely root cause is that the employees did not fully seat the valve in the oversleeve during the catheter assembly process per the applicable procedure which states: " rotate the valve/luer/catheter assembly while depressing the pedal until a small bead of epoxy is completely around connector between 1st and 2nd barbs.Verify epoxy does not extend onto shoulder or body of valve.If epoxy does extend onto valve, then use dry lint cloth to remove excess epoxy.Place the catheter/valve/luer assembly in the bonding fixture.Clamp at the extension so it does not slide." this is the only reported complaint for this failure mode in the past 15 months for the bioflo picc product family, as such, it is deemed to be an isolated incident.Operators performing the valve bonding sequence have been made aware of this complaint and have been re-trained on the proper assembly procedure.Although 100% visual inspection is currently performed on the bond joint, the procedure will be updated to include instructions requiring visualization to verify that luers are fully seated.(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: 8731561
• Report Number: 1317056-2019-00082
• Device Sequence Number: 2271360
• Product Code: LJS
• UDI-Device Identifier: H965750171
• UDI-Public: H965750171
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K163452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 01/31/2021
• Device Catalogue Number: H965750171
• Device Lot Number: 5445497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1