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

Catalog Number H96545832B0

Device Problem Reflux within Device (1522)

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

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

The used catheter has been returned for evaluation, however, the investigation is still in process.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported by angiodynamics' distributor in (b)(6), catheter was implanted in (b)(6) 2018 with no complications.Patient started the chemotherapy treatment and, on (b)(6) 2018, the catheter began refluxing (both ways).After 5 days, the catheter was replaced.The used device has been returned to angiodynamics.Patient condition was described as "satisfactory/good.".

Manufacturer Narrative

A review of the device history records was performed for the reported packaing lot (5320033) for item h965458320b0 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 complaint report was reviewed for the bioflo picc product family and the failure mode "valve bleed back." no adverse trend was identified.The bioflo picc from the reported event was returned.The catheter had been trimmed at the 35cm mark.The valves were visualized microscopically, and the slit in the gasket of the purple valve was closed and centered.During the cleaning process, the returned sample was flushed, with some difficulty, using a 10ml syringe through both lumens.The infusion and aspiration pressures were measured on the purple/purple and white/purple valves and were found to meet specification.The catheter tip id and od were also measured and met specification.The reported complaint was unable to be confirmed, nor could an exact root cause be identified, as no manufacturing nonconformances were observed during sample evaluation and the catheter was found to be visually, dimensionally, and functionally acceptable.The directions for use (dfu) packaged with the bioflo picc provides guidance on catheter use and maintenance.(pr (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: 8151619
• MDR Text Key: 129937852
• Report Number: 1317056-2018-00229
• Device Sequence Number: 1
• Product Code: LJS
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: H96545832B0
• Device Lot Number: 5320033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other