BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER

    MDR report key: 8325939 · Received February 11, 2019

    Report

    Report Number
    1416980-2019-00713
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Report Date
    April 28, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND IT WAS NOTED THAT BOTH RINGS OF THE COUPLER HAD PINS THAT WERE VISIBLY BENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED 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.

    Additional Manufacturer Narrative · 1

    CORRECTION WAS MADE TO THE PREVIOUSLY SUBMITTED: CATALOGUE #: PREVIOUSLY REPORTED 5121-00400-010 CORRECTED TO 5121-00400-060. LOT #: PREVIOUSLY REPORTED CORRECTED TO SP18B06-1270827. DEVICE MANUFACTURER INFORMATION FROM BAXTER HEALTHCARE CORPORATION CORRECTED TO SYNOVIS SURGICAL INNOVATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122830 COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR MVR BAXTER HEALTHCARE CORPORATION NA SP18B06-1270827

    Patients

    Seq Age Sex Outcome Treatment
    1