BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HYPOINT¿ HYPODERMIC NEEDLE

    MDR report key: 15563974 · Received October 7, 2022

    Report

    Report Number
    8041187-2022-00580
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903002535
    PMA / PMN Number
    K070440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1013936, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, DEVICE MANUFACTURE DATE: 16-FEB-2021. MEDICAL DEVICE LOT #: 1013938, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, DEVICE MANUFACTURE DATE: 26-FEB-2021. INVESTIGATION SUMMARY: NO SAMPLES, ONLY 2 PHOTOS, WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. AS THIS IS A MARKET EVENT, THE REPORTED CONDITION DETECTED IS NOT PART OF A SAMPLING PLAN THAT ALLOWS TO CONCLUDE ABOUT THE WHOLE BATCH, THEREFORE THE AQL IS NOT APPLICABLE. THE BATCH WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. CONSEQUENTLY, BDM-PS WILL NOT DEFINE CORRECTIVE OR PREVENTIVE ACTIONS FOLLOWING THE INVESTIGATION OF THIS COMPLAINT. 2 PHOTOS WERE OBSERVED TO HAVE THE NEEDLE BROKEN. IT WAS UNCLEAR TO WHETHER THE NEEDLE WAS FOUND BROKEN BEFORE, DURING OR AFTER USAGE, MAKING IT INCONCLUSIVE AT WHICH ACTION/STAGE THE NEEDLE WAS BROKEN. BASED ON THE SAMPLE ANALYSIS BD ASSIGNED A QUALITY CRITERIA THAT IS RELATED TO THE REPORTED CONDITION AND IDENTIFIED IN THE AGREED SPECIFICATION. AFTER REVIEWING THE OCCURRENCE, IRRESPECTIVE OF ROOT CAUSE, IT IS WITHIN THE SPECIFICATION AND NO FURTHER ACTION WILL BE ASSIGNED. THE REPORT WILL NOT BE UPDATED IF THE SAMPLE IS RECEIVED AFTER THE APPROVAL OF THIS REPORT. UNCONFIRMED: BD COULD NOT CONFIRM THE REPORTED CONDITION. NOTE: THIS IS THE CLASSIFICATION SINCE WE ARE UNABLE TO DETERMINE AT WHAT STAGE THE DAMAGE OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE BROKE IN THE AVONEX PEN. THIS OCCURRED ONCE EACH IN LOTS 1013936 AND 1013938. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER REGARDING THAT THE NEEDLE WAS BROKEN IN AN AVONEX PEN. ACCORDING TO THE PATIENT AND THE NURSE, THERE WAS NO OTHER PIECE OF NEEDLE TO BE FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511856 BD HYPOINT¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 300253 1013936 00382903002535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown