BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE AIR HOSE SCHRADER STEM 2 METERS

    MDR report key: 2993678 · Received March 7, 2013

    Report

    Report Number
    2520274-2013-01315
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS NOT THE LEGAL MANUFACTURER OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DHR REVIEW SHOWED THERE ARE NO KNOWN NCRS ASSCOICATED WITH THIS ITEM NUMBER/BATCH NUMBER. AFTER FURTHER REVIEW, IT WAS FOUND THAT THIS PART IS IN FACT A SYNTHES PART.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO: DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE MDR REPORT ABILITY STATUS UPDATED TO: DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT: #2520274-2013-01315.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A DOUBLE AIR HOSE SCHRADER WAS FOUND WITH THE INNER HOSE SEPARATED FROM THE OUTER HOUSE. THIS WAS DISCOVERED DURING TESTING. DEVICE WAS NOT USED IN SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013 A DOUBLE AIR HOSE SCHRADER WAS FOUND WITH THE INNER HOSE SEPARATED FROM THE OUTER HOUSE. THIS WAS DISCOVERED DURING TESTING. DEVICE WAS NOT USED IN SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97176 DOUBLE AIR HOSE SCHRADER STEM 2 METERS HSZ SYNTHES USA F353069303

    Patients

    Seq Age Sex Outcome Treatment
    1