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

Catalog Number 5111-00250-060

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 2.5mm coupler leaked upon closure.This was identified during use on a patient for an anastomosis procedure.This was further described as ¿upon closure of the coupler, alignment was incorrect, causing leakage¿.This resulted in an additional 30 minutes of surgery to remove and replace the coupler with a new coupler.There was no patient injury or medical intervention associated with this event.It was reported that ¿the patient was doing well¿.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.A visual inspection was performed which observed dried blood, dried tissue, and manipulation marks likely caused by a surgical instrument.Further investigated was performed which observed that there were no pin marks on the rings near the mating holes which would have been an indication of ring misalignment.Functional testing was not performed on the device.The reported condition was not verified.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
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9241930
• MDR Text Key: 164411499
• Report Number: 1416980-2019-05928
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5111-00250-060
• Device Lot Number: SP19F05-1377414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1