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

Catalog Number	5111-00300-060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2020
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 a 3.0mm coupler device had one side of the wing jaw that was broken; further described as a broken tip.This was identified during preparation for surgery.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed which observed the right jaw assembly was broken.The jaw was missing both the ring and half of the right jaw.The remaining coupler ring showed no signs of use.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 10730834
• Report Number: 1416980-2020-06610
• Device Sequence Number: 11627231
• Product Code: MVR
• UDI-Device Identifier: 00844735002676
• UDI-Public: 00844735002676
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 5111-00300-060
• Device Lot Number: SP20C13-1436267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1