BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT

    MDR report key: 12370030 · Received August 26, 2021

    Report

    Report Number
    0008031000-2021-00036
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    May 19, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). BATTERY FOR ASEPTIC TRANSFER KIT PART NUMBER 89-8510-440-20 SERIAL NUMBER (B)(6) WAS RETURNED FOR COMPLAINT INVESTIGATION. UPON RECEIPT, IT WAS CONFIRMED THAT THE BATTERY WAS MELTED. THERE WAS BURN DAMAGE ON THE LEFT SIDE OF THE DEVICE. BESIDES, THE RESISTORS AND CELLS WERE BURNT. THE DEVICE WAS NOT TECHNICALLY REPAIRABLE. DEVICE WAS RECYCLED IN ZIMMER GENEVA PREMISES AS PER CUSTOMER INSTRUCTION. DESIGN HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUE WAS DISCOVERED DURING THE MANUFACTURING PROCESS THAT COULD EXPLAIN THE DEFECT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CORNER OF THE BATTERY FOR ASEPTIC TRANSFER KIT, PART NUMBER 89-8510-440-20 SERIAL NUMBER (B)(6) AND LOT NUMBER 5010650, MELTED A LITTLE BIT. A SMELL OF BURNING WAS NOTICED BY THE STERILIZATION EMPLOYEE. ACCORDING TO THE HOSPITAL, THIS IS NOT DUE TO THE FACT THAT THE DEVICE WAS IN THE HEATER THAT STERILIZED THE INSTRUMENT. THE BATTERY WAS UNUSABLE. NO SURGERY WAS INVOLVED. THERE WAS NO HARM OR IMPACT TO THE PEOPLE AND ENVIRONMENT IN THE ROOM REPORTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NUMBER (B)(4). THE UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT, PART NUMBER 89-8510-440-20 SERIAL NUMBER (B)(4) AND LOT NUMBER 5010650, WAS RETURNED TO THE MANUFACTURER. HOWEVER, THE EVALUATION OF THE DEVICE IS NOT AVAILABLE YET AT THE DATE OF THE REPORT. A FOLLOW-UP MEDWATCH WILL BE SENT WHEN THE EVALUATION IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORNER OF THE BATTERY FOR ASEPTIC TRANSFER KIT, PART NUMBER 89-8510-440-20 SERIAL NUMBER (B)(4) AND LOT NUMBER 5010650, MELTED A LITTLE BIT. A SMELL OF BURNING WAS NOTICED BY THE STERILIZATION EMPLOYEE. ACCORDING TO THE HOSPITAL, THIS IS NOT DUE TO THE FACT THAT THE DEVICE WAS IN THE HEATER THAT STERILIZED THE INSTRUMENT. THE BATTERY WAS UNUSABLE. NO SURGERY WAS INVOLVED. THERE WAS NO HARM OR IMPACT TO THE PEOPLE AND ENVIRONMENT IN THE ROOM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268393 UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT MOQ ZIMMER SURGICAL SA NA 5010650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other