BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA TUBEASSEMBLY MIN-L 520 F/314.743

    MDR report key: 3026781 · Received March 29, 2013

    Report

    Report Number
    1719045-2013-00782
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: HRX. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR REVIEW INDICATED NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO MRRS OR NCRS, OR COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS LOT. THE INVESTIGATION HAS SHOWN THERE IS INDEED A HOLE IN THE INTERIOR ASEPTIC BAG. WE ARE NOT ABLE TO UNDERSTAND HOW THIS COULD HAPPEN, PROBABLY DURING THE TRANSPORTATION OR PACKAGING PROCESS. WE ARE NOT ABLE TO ELABORATE THE EXACT REASON WHICH HAS LED TO THIS PHENOMENON.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PART WAS PACKAGED PER PS024680 REVISION H AND MON URANIA REVISION V. THE TWO POUCHES THAT WERE USED TO PACKAGE THIS PRODUCT WERE PM0580 LOT NUMBER 6995072 AND PM0581 LOT NUMBER 6951345. BOTH WERE RECEIVED FROM MANGAR INDUSTRIES AND WERE INSPECTED TO POUCHII002 BOTH POUCHES PASSED INSPECTION. WITHOUT THE ORIGINAL PACKAGING THE COMPLAINT CONDITION CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE THEY FOUND HOLES IN THE PACKAGE OF THE RIA TUBE ASSEMBLY. THE DEVICE WAS NOT STERILE AND COULD NOT BE USED. THE OUTER CARTON WAS CHECKED: WAS INTACT WITH NO VISIBLE DAMAGE NOTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130223 RIA TUBEASSEMBLY MIN-L 520 F/314.743 HTO SYNTHES MONUMENT 7042606

    Patients

    Seq Age Sex Outcome Treatment
    1