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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 5111-00300-060
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation, free floating in a specimen jar without the white protective holder. Visual inspection was performed which observed dried blood on the left coupler ring indicating patient use. Further inspection was performed which revealed multiple bent pins on the left coupler ring. The visual inspection of the returned 3. 0mm coupler assembly verified bent coupler rings and revealed that the condition of the product returned was not consistent with the reported condition of damage found prior to patient use. The cause of the bent pins could not be determined. A device history review revealed no issues that could have caused or contributed to the reported issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
One 3. 0mm coupler 6/bx was returned for evaluation. This was initially reported as ¿the customer noticed one of six gem2754 3. 0mm couplers received in the carton was damaged. This was discovered while removing the individual units from the carton, prior to patient use. ¿ there was no patient involvement. 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 60073
2242702068
MDR Report Key10652261
MDR Text Key210609568
Report Number1416980-2020-06288
Device Sequence Number1
Product Code MVR
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5111-00300-060
Device Lot NumberSP20D20-1445339
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
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

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