COUPLER 5111-00200-060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for COUPLER 5111-00200-060 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[176877219] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[176877220] It was reported that the pin of a 2. 0mm coupler device was tilted obliquely. This issue was identified during patient use. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-00270
MDR Report Key9643433
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-29
Date of Report2020-03-12
Date of Event2019-12-19
Date Mfgr Received2020-02-28
Date Added to Maude2020-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1SYNOVIS SURGICAL INNOVATIONS
Manufacturer Street2575 UNIVERSITY AVE. W
Manufacturer CitySAINT PAUL MN 55114
Manufacturer CountryUS
Manufacturer Postal Code55114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2020-01-29
Returned To Mfg2020-02-10
Model NumberNA
Catalog Number5111-00200-060
Lot NumberSP18A25-1268820
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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