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

Catalog Number 511100100010

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

The 1.0mm coupler jaw assembly was received for evaluation.Visual inspection revealed that the 1.0mm ring was missing (dislodged) from the left jaw and the ring was properly seated in the right jaw.The cause of the condition could not be determined.Potential contributing causes could be inadvertent ring dislodgement during shipment to the customer or removal of the white plastic holder in preparation for the surgical process.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.

Event Description

During evaluation of a returned 1.0mm coupler jaw assembly, the ring from the left jaw was found to be missing and the ring from the right jaw was intact.There was no patient involvement.No additional information is available.

• Brand Name: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10609686
• MDR Text Key: 209334855
• Report Number: 1416980-2020-06104
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 511100100010
• Device Lot Number: SP19F06-1377925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1