BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BIOLOGICS COUNTERBALANCE

    MDR report key: 6639465 · Received June 14, 2017

    Report

    Report Number
    0001825034-2017-03847
    Event Type
    Injury
    Date Received
    June 14, 2017
    Report Date
    August 22, 2017
    Manufacturer
    BIOMET BIOLOGICS
    Product Code
    JQO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT DEVICE CODE = JQO.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO PATIENT INJURY NOR HARM. THE INITIAL REPORT WAS FILED IN ERROR AND SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE UTILIZING A GPS KIT, THE COUNTER BALANCE WATER TUBE BROKE DURING CENTRIFUGATION. A NEW COUNTERBALANCE WAS PLACED IN THE CENTRIFUGE AND THE BLOOD WAS SPUN TO COMPLETE THE PROCEDURE, AFTER DELAYING PROCEDURE FOR FORTY-FIVE (45) MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422025 BIOMET BIOLOGICS COUNTERBALANCE JQO BIOMET BIOLOGICS N/A 125033

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization