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

Catalog Number	H965458120
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
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 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
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8451147
• Report Number: 1317056-2019-00049
• Device Sequence Number: 11454500
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1