BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HYPOINT¿ HYPODERMIC NEEDLE

    MDR report key: 8125343 · Received December 3, 2018

    Report

    Report Number
    8041187-2018-00442
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 9, 2018
    Report Date
    December 12, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903002559
    PMA / PMN Number
    K070440
    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: IN EVALUATING THE RETURNED PHOTOS, BD WAS UNABLE TO DETERMINE WHETHER IT IS A FOREIGN MATTER. IN EVALUATION OF RETURNED SAMPLES, BD WAS ABLE TO OBSERVE THE FM. INSPECTION WAS PERFORMED AS THE FM SIZE IS FOUND TO BE <0.05MM2 WHICH IS WITHIN SPECIFICATION. FTIR ANALYSIS WAS PERFORMED ON THE FM AND OBSERVED TO BE PROTEIN. BASED ON DHR RECORD, THERE ARE NO ABNORMALITIES OBSERVED. PROTEIN OBSERVED MAYBE PRODUCED OUTSIDE THE MANUFACTURING FACILITY AS THIS IS NOT OBSERVE IN MANUFACTURING PROCESS. HENCE, ROOT CAUSE IS NOT ESTABLISHED. NO CAPA IS REQUIRED AS AWARENESS TRAINING ON THE COMPLAINT HAS BEEN PERFORMED ON 7 DECEMBER 2018 WHICH HAPPENED AFTER THE AFFECTED BATCHES PRODUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7051429. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2017-03-09. MEDICAL DEVICE LOT #: 7051442. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2017-03-09. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965526 BD HYPOINT¿ HYPODERMIC NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 00382903002559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other