BEUDAMED
    FDA Adverse Event Other Summary report: N

    OB PACK V

    MDR report key: 1562880 · Received December 9, 2009

    Report

    Report Number
    1417592-2009-00060
    Event Type
    Other
    Date Received
    December 9, 2009
    Report Date
    December 1, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    HFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A CORD CLAMP FAILED AND ONE INFANT REQUIRED A BLOOD TRANSFUSION. NO FURTHER COMPLICATION FOR THE INFANT WAS REPORTED. THE FACILITY STATED THERE WERE TWO PREVIOUS INSTANCES WHERE A CLAMP DID NOT HOLD. THERE WAS NO NEGATIVE CONSEQUENCES TO THE INFANTS INVOLVED IN THE FIRST TWO INSTANCES. ALL THREE INSTANCES INVOLVED THE SAME PHYSICIAN. NO ACTUAL SAMPLES WERE RETURNED FOR EVAL. THE FACILITY HAS USED THESE CLAMPS FOR QUITE SOME TIME AND STATES THERE HAVE NOT BEEN OTHER SIMILAR INSTANCES. THE PHYSICIAN WAS RE-INSERVICED BY THE FACILITY REGARDING USE OF THE CLAMP. SAMPLES FROM SAME LOT WERE PULLED FROM STOCK AND TESTED. THE CLAMPS WERE FOUND TO BE EFFECTIVE IN OCCLUDING THE FLOW OF FLUID AND THE ISSUE COULD NOT BE CONFIRMED. NO LEAKING WAS IDENTIFIED. AND UNUSED SAMPLE WAS ALSO RETURNED FROM THE ACCOUNT. IT WAS TESTED AND NO LEAKS WERE IDENTIFIED. WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE. HOWEVER, DUE TO THE FACT AN INFANT REQUIRED A BLOOD TRANSFUSION, THIS MDR IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORD CLAMP WAS NOT SECURE. THE INFANT REQUIRED A TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB PACK V CORD CLAMP WITHIN HFW MEDLINE INDUSTRIES, INC. DYNJP6040 A94298262

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention