BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HKL SET REGIONAL SPITAL BIEL

    MDR report key: 1250878 · Received December 2, 2008

    Report

    Report Number
    1526863-2008-00063
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBASSEMBLY IN QUESTION IS A387 AND IS MANUFACTURED BY SMITHS MEDICAL. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT (B) (4) BY SMITHS MEDICAL (B) (4). THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL (B) (4). TWO SAMPLES WERE RECEIVED WITH THE ROTATORS SEPARATED FROM THE SYRINGES ON BOTH UNITS. THERE WAS NO SOLVENT PRESENT ON THE MALE TAPER OF THE SYRINGE DUE TO A BONDING ISSUE. AS A CORRECTION, MFG PERSONNEL WERE RETRAINED ON PROPER BONDING AND ASSEMBLY PROCEDURES IN SEPTEMBER 2008. THE LOT IN QUESTION WAS MANUFACTURED BEFORE THIS CORRECTION HAD BEEN COMPLETED. SMITHS WAS ABLE TO CONFIRM THE ISSUE AND DETERMINE THE CAUSE. CORRECTIONS HAVE BEEN COMPLETED AND THE ISSUE IS BEING MONITORED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE ROTATING ADAPTER OF THE SYRINGE IS LOOSE AND DOES NOT HOLD. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HKL SET REGIONAL SPITAL BIEL PRESSURE MONITORING SET DRS SMITHS MEDICAL ASD, INC. NA 724119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK