MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3.5MM COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 512100350060

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 3.5mm coupler "ring detached from u-port and had to be replaced during set up".This issue was identified before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: one coupler ring and jaw assembly was returned for evaluation.A visual inspection on the coupler observed signs of use (dried blood and manipulation marks most likely caused by a surgical instrument) which is not consistent with the alleged issue being discovered before use as stated within the complaint record.The second ring not being returned, it can be assumed that either one or both rings dislodged from the u-port.No cause for the allegation of ¿ring dislodgement¿ could be determined based on investigation of the returned coupler rings.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: 3.5MM COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9459986
• MDR Text Key: 170523855
• Report Number: 1416980-2019-06855
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 512100350060
• Device Lot Number: SP19D12-1366634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1