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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 511100150060
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the pin of a 1.5mm coupler was observed bent.This issues was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d10, h3 and h6.H10: the device was received for evaluation.Visual inspection was done to the right ring which observed two bent pins were visible.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 Key10136504
MDR Text Key194604051
Report Number1416980-2020-03257
Device Sequence Number1
Product Code MVR
UDI-Device Identifier10844735002628
UDI-Public10844735002628
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 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511100150060
Device Lot NumberSP19I11-1395812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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