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

Catalog Number H965458120

Device Problem Reflux within Device (1522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device from the reported event has been returned to angiodynamics, however the device analysis is in process.Upon conclusion of the investigation, a supplemental medwatch will be submitted.((b)(6)).

Event Description

As reported by angiodynamics' distributor in (b)(6): immediately after picc placement, the patient went for cxr post-insertion as normal."cathy then checked the picc to find blood pushing back down the picc as if there was no valve on the end of the picc.She had to remove the picc and replace with a new one".No injury to the patient was reported.The used catheter has been returned to angiodynamics for evaluation.

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 2019 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "valve bleed back." no adverse trend was identified.As received, the sl bioflo picc had been trimmed at the 25cm mark.When the valve was visualized microscopically, the slit in the gasket of the valve was closed and centered.Functional check for aspiration pressure was verified on the pasv valve using a water column and a ruler: the sample met specification of 200-300 cm h2o.The reported complaint description was unable to be confirmed.No manufacturing non-conformances were observed during the sample evaluation and the valve met aspiration pressure specification.The root cause of the reported event was inconclusive, as the sample was found to be visually and functionally acceptable.The directions for use packaged with the bioflo picc device include a recommended procedure for blood sampling.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8451147
• MDR Text Key: 139808665
• Report Number: 1317056-2019-00049
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (y/n): N
• PMA/PMN Number: K121089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: H965458120
• Device Lot Number: 5373692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1