BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN MEDICAL SYSTEM

    MDR report key: 863062 · Received March 6, 2007

    Report

    Report Number
    1221538-2007-00002
    Event Type
    Other
    Date Received
    March 6, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 6, 2007
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    HXD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGED CLAMP INVOLVED IN THIS INCIDENT HAD THE TOP PRONGS PEELED BACK TO THE POINT OF BREAKING. IT DID NOT EXHIBIT MFG DEFECTS (MISSING OR POORLY ASSEMBLED COMPONENTS) OR RAW MATERIAL DEFECTS (VOIDS IN THE MATERIAL OR STRESS LINES). ENGINEERING REVIEWED THE PROD AND CONCLUDED THAT THE CLAMP INVOLVED IN THIS INCIDENT DEMONSTRATED UNCHARACTERISTIC WEAR. ALL INDICATIONS WERE CONSISTENT WITH IMPROPER APPLICATION / CUSTOMER MISUSE. IT APPEARS THAT THIS WEAR WAS NOT THE RESULT OF A SINGLE EVENT BUT AS THE RESULT OF A PRIOR PROCEDURE(S) IN WHICH THE CLAMP WAS USED IMPROPERLY. (WEAKENED IN ONE PROCEDURE AND FAILING IN ANOTHER). THE WEAKENING OF THE CLAMP IS BELIEVED TO BE THE RESULT OF THE CLAMP BEING USED TO BRIDGE THE GAP BETWEEN THE RAIL BRAKES ON A BED OR ON AN OR TABLE. THIS TYPE OF MISUSE IS RECOGNIZED AND WARNED ABOUT IN THE DOCUMENTED IN-SVC INSTRUCTION FOR THIS PROD. IN ADDITION TO THE WARNING WHICH ACCOMPANIES THE CLAMPS, THE DEVICES ALSO CLEARLY EXHIBIT DAMAGE AND WEAR. THEY ARE DARK BLACK AND THE COMPOSITE MATERIAL BENEATH IS SILVER-COLORED. WHERE THERE IS DAMAGE OR WEAR ON THE CLAMP, THE WEAR-SPOT IS HIGHLY VISIBLE. AFTER RELAYING OUR FINDINGS, THE FACILITY REP REQUESTED AN INSERVICE TRAINING FOR CLAMP INSTALLATION. THIS WAS PROVIDED BY A QUALIFIED ALLEN REP.

    Description of Event or Problem · 1

    IN 2007, ALLEN WAS MADE AWARE OF A CLAMP BREAKING DURING USE IN A PT PROCEDURE AT THE HOSP . THIS IS A COMMON RAIL CLAMP WHICH ATTACHES TO THE SIDE OF BEDS OR SURGICAL TABLES AND ALLOWS STIRRUPS OR OTHER OPERATING ROOM ACCESSORIES TO BE USED IN PROCEDURES. THE CLAMP FAILED DUE TO THE TOP PRONGS (WHICH WRAP AROUND THE TOP END OF THE RAIL) BEING PRIED AWAY FROM THE REMAINING CLAMP BODY. THERE WAS NO INJURY TO REPORT WITH THIS INCIDENT. THE PROCEDURE WAS NOT DELAYED SIGNIFICANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM RAIL CLAMP HXD ALLEN MEDICAL SYSTEMS, INC. O-RC2-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention