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

Catalog Number 511100250060

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

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 a pin of a 2.5mm coupler - 6/bx was detached to u-port.The issue was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 12383510
• MDR Text Key: 268675234
• Report Number: 1416980-2021-05296
• 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: 10/05/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 511100250060
• Device Lot Number: SP20H19-1471158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1