BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION

    MDR report key: 11620292 · Received April 6, 2021

    Report

    Report Number
    2243072-2021-00955
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NINE USED SAMPLES WERE RETURNED BY THE CUSTOMER. THROUGH VISUAL INSPECTION, SEVEN SAMPLES WERE FOUND TO HAVE A SEPARATED MALE LUER. FROM THESE SEVEN, ONE OF THE MALE LUERS WERE FOUND WITH A BIG CRACK. TWO SAMPLES WERE RETURNED WITH NO DEFECTS OR DAMAGES. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE FOR THE SEPARATION OF THE MALE LUER WAS DETERMINED TO BE AN INSUFFICIENT AMOUNT OF SOLVENT ADDED AT THE BONDING SITE. THE ROOT CAUSE FOR THE DAMAGE ON THE MALE LUER WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED DURING USE. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ INFUSION SAMPLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT SAMPLES HAD BROKEN TRIFUSE. VERBATIM: - PR FOR BROKEN TRIFUSE BUT DIFFERENT MATERIAL # SAMPLES 11, 12, 33, 37, 38, 41, 43, 45, 57.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ INFUSION SAMPLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT SAMPLES HAD BROKEN TRIFUSE. VERBATIM: PR FOR BROKEN TRIFUSE BUT DIFFERENT MATERIAL # SAMPLES 11, 12, 33, 37, 38, 41, 43, 45, 57.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515745 UNSPECIFIED BD INFUSION INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1