MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 5111-00300-010

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 3.0mm coupler did not stay closed when the coupler was engaged; the coupler fell apart.This issue was identified during patient use.A new coupler was used to complete the procedure.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.A visual inspection revealed signs of use in both returned coupler rings (dried blood, dried tissue) and slight signs of approximation (a small indent in the ring near the mating hole made by the opposing pin).Additional inspection was performed which revealed that one of the rings had a visible bent pin.The reported condition was verified.The cause of the condition was not determined.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9411113
• MDR Text Key: 169213319
• Report Number: 1416980-2019-06678
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: K861985
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5111-00300-010
• Device Lot Number: SP19H30-1399640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1