COUPLER 5121-00400-010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-11 for COUPLER 5121-00400-010 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[135725278] The customer reported a potential lot number of gem2756 sp18b06-1270827. This lot number is not recognized by baxter. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[135725279] It was reported that a pin on a coupler device was bent. This was identified when the surgeon took the coupler out of the package during set-up and preparation. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2019-00713
MDR Report Key8325939
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-02-11
Date of Report2019-03-13
Date Mfgr Received2019-03-01
Date Added to Maude2019-02-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 G1BAXTER HEALTHCARE CORPORATION
Manufacturer StreetNI NI
Manufacturer CityNI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2019-02-11
Returned To Mfg2019-02-14
Model NumberNA
Catalog Number5121-00400-010
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressNI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-11

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