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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Catalog Number 511100200060
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the ring of a 2. 0mm coupler was unable to fully attach. This was identified during patient use. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCOUPLER
Type of DeviceDEVICE, 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 
2242702068
MDR Report Key12615497
MDR Text Key276123929
Report Number1416980-2021-06212
Device Sequence Number1
Product Code MVR
Combination Product (y/n)Y
Reporter Country CodeTW
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511100200060
Device Lot NumberSP21D14-1525525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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