BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 8057357 · Received November 9, 2018

    Report

    Report Number
    3002682307-2018-00278
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903008025
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. NEEDLES WERE PACKED IN MACHINE 2104 (JULY 31 ¿ AUGUST 3RD 2017) DURING WHICH 65 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECT NOTED. PICTURES SHOW INNER PLASTIC BAG LABEL A DIFFERENT BATCH NUMBER: (8192814) AS A SHIPPING BOX LABEL/CARTON STICKER (8197788) AS EXPECTED, BECAUSE IT IS DIFFERENT REFERENCE AS WELL: INNER MATERIAL 3002112FRA, AND FINAL MATERIAL 300802. INVESTIGATION CONCLUSION: THE REPORTED FAILURE MODE DOES NOT CORRESPOND TO ANY QUALITY ISSUE EVEN LABELLING ERROR IN THE PRODUCT: THE BATCH NUMBER: (8192814) AND PRODUCT REFERENCE IS LOCATED ONLY IN THE LABELLING OF THE EXTERNAL PACKAGE (SHIPPING CASE). THE LABEL LOCATED IN THE INNER BAG (PLASTIC BAG CONTAINING THE NEEDLES) CORRESPONDS TO ASSEMBLED NEEDLES (8192814), THIS IS MAINTAINED FOR A TRACEABILITY PURPOSE. THIS IS A DIFFERENT BATCH, BECAUSE THIS IS ALSO A DIFFERENT REFERENCE (ASSEMBLED VS FINAL PRODUCT). BOTH MATERIALS AND BATCHES (FINAL PRODUCT IN BULK AND ASSEMBLED PRODUCT) ARE LINKED WITHIN THE BHR AND PERMIT US TO HAVE A FULL TRACEABILITY FOR THE PRODUCT FROM RAW MATERIALS TO FINAL PRODUCT. IT IS IMPORTANT TO TAKE INTO CONSIDERATION THAT ALL BULK PRODUCT WILL SHOW THIS IDENTIFICATION (ASSEMBLY BATCH NUMBER IN INNER BAG WILL BE ALWAYS DIFFERENT FROM THE SAP CERTIFICATE, PO AND SHIPPING BOX LABEL LOT NUMBER) AND SHOULD NOT BE CONSIDERED AS A DEFECT NEITHER A COMPLAINT. IN ADDITION, WE HAVE BEEN USING THIS PRODUCT IDENTIFICATION FOR MANY YEARS AND THIS IS A STANDARD REFERENCE FOR MULTIPLE CUSTOMERS. ROOT CAUSE DESCRIPTION: NO DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD MICROLANCE¿ NEEDLE HAD DIFFERENT BATCH LABELING BETWEEN THE DELIVERY NOTE AND CARTON STICKER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 A BD MICROLANCE¿ NEEDLE HAD DIFFERENT BATCH LABELING BETWEEN THE DELIVERY NOTE AND CARTON STICKER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893860 BD MICROLANCE¿ NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 8197788 00382903008025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other