BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE 32X4 LA 5B

    MDR report key: 8884840 · Received August 12, 2019

    Report

    Report Number
    9616657-2019-00310
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) OPEN 4MM, 32G PEN NEEDLE FROM LOT#: 8242669. CUSTOMER STATES THAT THE NEEDLES WERE CLOGGED. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BENT NON PATIENT END OF THE CANNULA WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA PROPERLY. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PEN NEEDLE 32X4 LA 5B THREE NEEDLES WERE CLOGGED OUT OF THE BATCH. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. TRANSLATED FROM PORTUGUESE TO ENGLISH: INFORMS THAT IN THE LAST BATCH, 3 NEEDLES WERE CLOGGED. SHE PERFORMED THE FLOW TEST, WHERE SHE FOUND THAT THE DEVIATION WAS PROBABLY EVEN ON THE BD NEEDLES. YOU DO NOT SEE ANY APPARENT DEFECT IN THE NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PEN NEEDLE 32X4 LA 5B THREE NEEDLES WERE CLOGGED OUT OF THE BATCH. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: INFORMS THAT IN THE LAST BATCH, 3 NEEDLES WERE CLOGGED. SHE PERFORMED THE FLOW TEST, WHERE SHE FOUND THAT THE DEVIATION WAS PROBABLY EVEN ON THE BD NEEDLES. YOU DO NOT SEE ANY APPARENT DEFECT IN THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676913 BD PEN NEEDLE 32X4 LA 5B PEN NEEDLE FMI BECTON, DICKINSON AND CO. 8242669

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other