BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SECONDARY SET C61

    MDR report key: 16006043 · Received December 19, 2022

    Report

    Report Number
    2243072-2022-02177
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 29, 2022
    Report Date
    January 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    00382905153020
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1022536. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A PHOTOGRAPH WAS SUBMITTED TO OUR FACILITY, WHICH DISPLAYED THE REPORTED LEAKAGE OCCURRING BETWEEN THE TUBE AND SPIKE. THE ISSUE HAS BEEN CONFIRMED. OUR ENGINEERS HAVE FURTHER IDENTIFY THE MOST LIKELY ROOT CAUSE AS TOO LITTLE SOLVENT ON THE JOINT, WHICH DIRECTLY LEAD TO THE LEAK. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS NOT REGISTERED WITH THE FDA. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SECONDARY SET C61 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING INFUSION CAUSING SPILLAGE IN THE WARDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SECONDARY SET C61 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING INFUSION CAUSING SPILLAGE IN THE WARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126496 BD PHASEAL¿ SECONDARY SET C61 INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1022536 00382905153020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown