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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 511100300060
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 3.0mm coupler "ring detached from u-port and had to be replaced during set up".There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.Visual inspection identified signs of use (dried blood, tissue, manipulation marks).The rings were misaligned within the jaw assembly (ring rails not sitting correctly within the jaw slots) of the coupler which indicates that the rings had detached from the u-port (jaw).The reported condition was verified.The cause of the condition could not be determined.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.
 
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Brand Name
COUPLER
Type of Device
DEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9462056
MDR Text Key170680858
Report Number1416980-2019-06857
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
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 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511100300060
Device Lot NumberSP19E22-1374444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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