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

Catalog Number 515101200010

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during anastomosis with a flow coupler, there was a ring dislodgement and the rings were found not to be aligned.It was reported that after integrating the probe to the applicator, it became detached.This happened before patient use.A second coupler was used to perform the anastomosis.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d10, h3, h6 and h10.The jaw assembly with the coupler ring and the flow coupler ring with a probe inserted were returned for evaluation.Both the flow coupler ring and the coupler ring that remained in the jaw assembly showed signs of use.Visual inspection found the flow coupler ring was no longer seated in the jaw assembly.The reported condition was verified.It is possible that the actual issue with the product was that the ring had dislodged from the jaw assembly in preparation for the surgical process and not the probe from the ring, however, this cannot be confirmed.The cause of the condition could not be 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: FLOW COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10687104
• MDR Text Key: 211633752
• Report Number: 1416980-2020-06441
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 00844735005998
• UDI-Public: 00844735005998
• Combination Product (y/n): Y
• PMA/PMN Number: K132727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 515101200010
• Device Lot Number: SP18I25-1326306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1