MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; CATHETER, INTRAVASCULAR, SHORT-TERM

Catalog Number H965464701

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

The device from the reported event is expected to be returned to angiodynamics for evaluation, but has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported, the picc hub detached from the extension leg.The device was removed and the catheter was replaced.No complications to the patient were reported.

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 february 2018 angiodynamics complaint report was reviewed for the bioflo midline picc product family and the failure mode "hub detached - catheter removed." no adverse trend was identified.The reported complaint description cannot be confirmed, nor can a root cause be determined, as no sample was returned to angiodynamics for evaluation.No sample was returned.This is the only reported complaint for this failure mode in the past 15 months for the bioflo midline picc product family.Angiodynamics manufacturing process controls for this device include a 100% in-process visual inspection for molding defects and a guidewire insertion test to verify lumen patency.The guidewire must pass through the catheter with little to no resistance to be considered acceptable.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Type of Device: CATHETER, INTRAVASCULAR, SHORT-TERM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7274490
• MDR Text Key: 100266790
• Report Number: 1317056-2018-00012
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: H965464701
• UDI-Public: H965464701
• Combination Product (y/n): N
• PMA/PMN Number: K150407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965464701
• Device Lot Number: 5206711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1