BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 12279769 · Received August 5, 2021

    Report

    Report Number
    0008031000-2021-00033
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 26, 2021
    Report Date
    November 2, 2021
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). TWO ATTEMPTS WERE SENT TO THE CUSTOMER TO RETRIEVE THE UNIVERSAL ASEPTIC TRANSFER KIT HOUSING, PART NUMBER 89-8510-440-10, LOT NUMBER 5010988. HOWEVER, WE RECEIVED THE INFORMATION THAT THE PRODUCT WILL NOT BE RETURNED. ALSO, A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR THIS PRODUCT PART NUMBER 89-8510-440-10 LOT NUMBER 5010988. NO ISSUE WAS FOUND DURING THE MANUFACTURING PROCESS THAT COULD EXPLAIN THE DEFECT REPORTED. ANOTHER FOLLOW-UP MEDWATCH WILL BE PERFORMED IF THE PRODUCT IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10 LOT NUMBER 5010988 WAS OPENED DURING THE SURGERY IN THE STERILE AREA DUE TO BROKEN LOCKS. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE DATE OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE PERFORMED IF NEW INFORMATION OR PRODUCT IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10 LOT NUMBER 5010988 WAS OPENED DURING THE SURGERY IN THE STERILE AREA DUE TO BROKEN LOCKS. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE.. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178182 UNIVERSAL ASEPTIC TRANSFER KIT HOUSING ASEPTIC TRANSFER KIT HOUSING MOQ ZIMMER SURGICAL SA 5010988

    Patients

    Seq Age Sex Outcome Treatment
    1 Other