BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 8123638 · Received December 3, 2018

    Report

    Report Number
    0008031000-2018-00028
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ASEPTIC TRANSFER KIT HOUSING, LOT NUMBER 5010442 WAS RETURNED FOR COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL TEST WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT THE CONTACTS WERE DAMAGED AND DEVICE HAD A LEAKAGE ISSUE AT THE LEVEL OF THE LID. DEVICE WAS NOT REPAIRABLE, IT WAS RECYCLED IN ZIMMER GENEVA PREMISES ACCORDING TO CUSTOMER INSTRUCTIONS. THE EVENT DATE WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10, LOT NUMBER 5010442 WAS BROKEN. DURING THE EVENT, ANOTHER DEVICE, ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10, LOT NUMBER 5009013 WAS ALSO DETECTED AS BROKEN. THE SURGERY WAS DELAYED BETWEEN 30 TO 45 MINUTES DUE TO THE TIME NEEDED TO CHANGE THE PRODUCTS. THERE WAS NO ADDTIONAL HARM OR INJURY TO THE PATIENT OR OPERATOR REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE DATE OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED OR IF ANY ADDITIONAL INFORMATION 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 5010442 WAS BROKEN. DURING THE EVENT, ANOTHER DEVICE, ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10, LOT NUMBER 5009013 WAS ALSO DETECTED AS BROKEN. THE SURGERY WAS DELAYED BETWEEN 30 TO 45 MINUTES DUE TO THE TIME NEEDED TO CHANGE THE PRODUCTS. THERE WAS NO ADDITIONAL HARM OR INJURY TO THE PATIENT OR OPERATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966538 ASEPTIC TRANSFER KIT HOUSING ASEPTIC TRANSFER KIT HOUSING MOQ ZIMMER SURGICAL SA NA 5010442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other