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

Catalog Number 511100250060

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

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 the ring of 2.5mm coupler - 6/bx failed to detach during use.Another coupler was used to completed the case.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3 and h6.H10: the device was received for evaluation.Visual inspection was performed which observed evidence of use dried blod/tissue.Further inspection was performed which revealed that the jaw assembly had both rings intact; however, not properly seated in the jaw assembly.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: 10810304
• MDR Text Key: 215330478
• Report Number: 1416980-2020-06963
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 10844735002666
• UDI-Public: 10844735002666
• Combination Product (y/n): Y
• PMA/PMN Number: K861985
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511100250060
• Device Lot Number: SP20D201445245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1