BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER DUAL SPIKE

    MDR report key: 3030967 · Received April 2, 2013

    Report

    Report Number
    1017294-2013-00009
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CONMED
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: THREE (3) UNOPENED PACKAGES WERE RECEIVED FOR EVALUATION. VISUAL EXAMINATION FOUND ALL 3 POUCHES WERE SHOWING PUNCTURE-LIKE HOLES ON THE FILM SIDE OF THE POUCH. IT WAS ALSO NOTICED THAT ONE OF THE POUCHES HAS A PUNCTURE HOLE ON THE TYVEK SIDE AS WELL. TWO PACKAGES WERE FURTHER EVALUATED BY THE PACKAGING ENGINEER AND AFTER A THOROUGH REVIEW OF THE SAMPLES, THE ENGINEER CONCLUDED THAT THE PUNCTURE IN THE BLISTER PACKAGE WAS CAUSED BY THE CLAMP OF THE DUAL SPIKE ADAPTOR. BASED ON THIS FINDING, IT IS BELIEVED THAT THIS TYPE OF DAMAGE COULD HAVE OCCURRED DURING SHIPPING AND/OR HANDLING OF THE DEVICE. (B)(4).. RISK EVALUATION SHOWS THIS FAILURE CONTINUES TO BE AT AN ACCEPTABLE RISK LEVEL. IN ADDITION, AN INVESTIGATION WAS GENERATED TO ADDRESS THIS REPORTED PROBLEM. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCTS OCCURS MULTIPLE TIMES PRIOR TO USE (SHIPPING/RECEIVING, DISTRIBUTION, STORAGE AND IMMEDIATELY PRIOR TO USE). GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. ADDITIONALLY, THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) WARNS: IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE (3) OUT OF THE TEN (10) PACKAGES CONTAINING THE ADAPTER DUAL SPIKES WERE FOUND TO HAVE PUNCTURE HOLES ON THE FILM SIDE OF THE POUCHES CAUSING A BREACH IN STERILITY. IT WAS FURTHER REPORTED THAT THE DAMAGE TO THE PACKAGES WAS DISCOVERED DURING THE RESTOCKING OF THE PRODUCTS. THE OUTER BOX WAS IMMEDIATELY EXAMINED AND THERE WERE NO VISIBLE SIGNS OF DAMAGE. SINCE THE PUNCTURE HOLES WERE NOTICED WHILE RESTOCKING, THE PRODUCTS WERE NOT USED AND THUS THERE WAS NO PATIENT INVOLVEMENT. THE OTHER SEVEN (7) PACKAGES WERE PLACED IN STOCK FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135281 ADAPTER DUAL SPIKE ARTHROSCOPE HRX CONMED 87101 1212144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other