MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2.0MM COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 5111-00200-060

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 2.0mm coupler device had a steel needle on one side of the anastomotic ring that was bent.This issue was identified when opening the package for use.A new coupler was used to complete procedure.There was no 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.A visual inspection was performed, and it was noted that the rings showed signs of use (dried blood) which is consistent with the complaint¿s statement that the bent pin was found during use.When viewing the right ring of the 2.0mm coupler jaw assembly, a bent pin was visible.The reported condition was verified.The cause of the reported 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: 2.0MM COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10445775
• MDR Text Key: 204164501
• Report Number: 1416980-2020-05159
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 10844735002642
• UDI-Public: 10844735002642
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5111-00200-060
• Device Lot Number: SP19G01-1382542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1