BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 12330049 · Received August 17, 2021

    Report

    Report Number
    0008031000-2021-00034
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 21, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). AFTER SEVERAL ATTEMPTS, THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10 LOT NUMBER 5013972 WAS NOT RETURNED FOR COMPLAINT INVESTIGATION. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR THIS PRODUCT PART NUMBER 89-8510-440-10 LOT NUMBER 5013972. DEVIATIONS AND/OR NON CONFORMITIES WERE REVIEWED AND NONE OF THEM COULD EXPLAIN THE DEFECT REPORTED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS PERFORMED TO ADD INFORMATION THAT A DELAY OF 20 MINUTES WAS REPORTED. THE REASON OF THE DELAY IS THE FIELD HAD TO BE DISINFECTED WITH BRAUNOL + 0,9% NACL, CLOTHES CHANGED AND THE STAFF WASHED HANDS. 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 · 0

    IT WAS REPORTED THAT THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10 LOT NUMBER 5013972 WAS OPENED DURING THE SURGERY IN THE STERILE AREA. THE BATTERY AND THE SCREW WITH A COVER FELL TO A STERILE DRAPE NEAR THE OPERATING FIELD. THE PATIENT WAS UNDER SPINAL ANESTHESIA. 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. THIS FOLLOW-UP REPORT IS PERFORMED AS NEW INFORMATION WAS RECEIVED:A DELAY OF 20 MINUTES WAS REPORTED. THE REASON OF THE DELAY IS THE FIELD HAD TO BE DISINFECTED WITH BRAUNOL + 0,9% NACL, CLOTHES CHANGED AND THE STAFF WASHED HANDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTIC TRANSFER KIT HOUSING PART NUMBER 89-8510-440-10 LOT NUMBER 5013972 WAS OPENED DURING THE SURGERY IN THE STERILE AREA. THE BATTERY AND THE SCREW WITH A COVER FELL TO A STERILE DRAPE NEAR THE OPERATING FIELD. THE PATIENT WAS UNDER SPINAL ANESTHESIA. 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. THIS FOLLOW-UP REPORT IS PERFORMED AS NEW INFORMATION WAS RECEIVED:A DELAY OF 20 MINUTES WAS REPORTED. THE REASON OF THE DELAY IS THE FIELD HAD TO BE DISINFECTED WITH BRAUNOL + 0,9% NACL, CLOTHES CHANGED AND THE STAFF WASHED HANDS.

    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 5013972 WAS OPENED DURING THE SURGERY IN THE STERILE AREA. THE BATTERY AND THE SCREW WITH A COVER FELL TO A STERILE DRAPE NEAR THE OPERATING FIELD. THE PATIENT WAS UNDER SPINAL ANESTHESIA. 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
    1227784 UNIVERSAL ASEPTIC TRANSFER KIT HOUSING ASEPTIC TRANSFER KIT HOUSING MOQ ZIMMER SURGICAL SA 5013972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other