BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 9304228 · Received November 11, 2019

    Report

    Report Number
    3002682307-2019-00602
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS NOT PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304432 LOT 180105 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE NEEDLE WAS BLOCKED WITH A BD MICROLANCE¿ 3 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTER CLAIMED THAT THE RECONSTITUTED SUSPENSION COULD NOT BE INJECTED VIA THE NEEDLE PRESENT IN THE PACK. THEY TOOK ONE OF THEIR OWN NEEDLES AND THEN IT COULD BE INJECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE NEEDLE WAS BLOCKED WITH A BD MICROLANCE¿ 3 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTER CLAIMED THAT THE RECONSTITUTED SUSPENSION COULD NOT BE INJECTED VIA THE NEEDLE PRESENT IN THE PACK. THEY TOOK ONE OF THEIR OWN NEEDLES AND THEN IT COULD BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097473 BD MICROLANCE¿ 3 NEEDLES NEEDLE FMI BECTON DICKINSON, S.A. 180105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other