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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 5111-00250-010
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a 2.5mm coupler would not close.It was further reported during an anastomosis of the vein, 'the ring in the coupler did not clamp together".There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h6.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
COUPLER
Type of Device
DEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11223087
MDR Text Key228665881
Report Number1416980-2021-00131
Device Sequence Number1
Product Code MVR
Combination Product (y/n)Y
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/24/2021
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 Number5111-00250-010
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/29/2020
Initial Date FDA Received01/25/2021
Supplement Dates Manufacturer Received02/12/2021
Supplement Dates FDA Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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