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

Catalog Number	515101200010
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10687104
• Report Number: 1416980-2020-06441
• Device Sequence Number: 19635460
• Product Code: MVR
• UDI-Device Identifier: 00844735005998
• UDI-Public: 00844735005998
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K132727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1