BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HYPOINT¿ HYPODERMIC NEEDLE

    MDR report key: 8237059 · Received January 10, 2019

    Report

    Report Number
    8041187-2018-00514
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 25, 2018
    Report Date
    February 6, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903002559
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. FROM THE RETURNED SAMPLES, FM1 CAN BE OBSERVED. FM 2 AND 3 IS NOT CLEAR ENOUGH TO IDENTIFY THE FM. RETURNED SAMPLES ABLE TO OBSERVE ONLY FM1 WHICH IS PLACED ON THE GLASS PLATE. THE FM SIZE DID NOT PASS CRITERIA FOR BDJ LOOSE FM OUTSIDE HUB (>0.05MM2 AND <0.1MM2). FTIR ANALYSIS WAS PERFORMED ON FM1 AND OBSERVED INORGANIC MATERIAL. IT IS SUSPECTED THAT THE INORGANIC MATERIAL MIGHT BE FROM ENVIRONMENT. -WILL COMMUNICATE TO MANUFACTURING ASSOCIATES ON THE AWARENESS OF THIS COMPLAINT EMPHASIZE ON GMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND NEAR THE EPOXY AND ON THE NEEDLE HUB OF THE BD HYPOINT¿ HYPODERMIC NEEDLES AFTER REMOVING THEIR NEEDLE SHIELDS. LOT #S 7051492 AND 7075224 RESPECTIVELY WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT THE NUMBER OF OCCURRENCES FOR EACH IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7051492, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2017-03-15. MEDICAL DEVICE LOT #: 7075224, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-04-11. 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 WHITE FOREIGN MATTER WAS FOUND NEAR THE EPOXY AND ON THE NEEDLE HUB OF THE BD HYPOINT¿ HYPODERMIC NEEDLES AFTER REMOVING THEIR NEEDLE SHIELDS. LOT #S 7051492 AND 7075224 RESPECTIVELY WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT THE NUMBER OF OCCURRENCES FOR EACH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25560 BD HYPOINT¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10. 00382903002559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other