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

Catalog Number	5111-00150-060
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a steel needle of the 1.5mm coupler was bent on one side of the anastomosis ring.It was further reported that the other steel needles were loose and could not be used.This issue was identified during patient use.The coupler was replaced to complete the surgery and the patient was well.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: 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
• Common Device Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11135240
• Report Number: 1416980-2020-08399
• Device Sequence Number: 4126263
• Product Code: MVR
• UDI-Device Identifier: 10844735002628
• UDI-Public: 10844735002628
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 5111-00150-060
• Device Lot Number: SP20C17-1436855
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1