BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 14159810 · Received April 20, 2022

    Report

    Report Number
    9616656-2022-00437
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 1278330 : DEVICE EXPIRATION DATE : 30-SEP-2026. DEVICE MANUFACTURE DATE : 05-OCT-2021. LOT # : 1132267: DEVICE EXPIRATION DATE : 31-MAY-2026. DEVICE MANUFACTURE DATE : 12-MAY-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUTION?:YES D9: RETURNED TO MANUFACTURER ON: 12-APR-2022 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 13 USED 4MM, 32 GAUGE NANO PRO PEN NEEDLES. NO TEARDROP LABELS WERE RETURNED FOR LOT IDENTIFICATION. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING. 4 OF THE PEN NEEDLES WERE FOUND TO HAVE BENT NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. ADDITIONALLY, 9 WERE BROKEN ON THE SAME SIDE. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING OR BREAKING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, BD FOUND THAT 4 PEN NEEDLES HAD BECOME BENT AND 9 HAD BEEN BROKEN ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. THE ROOT CAUSE OF THE NEEDLES BENDING AND BREAKING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION THAT THE NEEDLE WAS CLOGGED SINCE INSULIN WOULD BE UNABLE TO PASS THROUGH THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE CLOG DURING INJECTION AND STATED THAT THERE IS NO INSULIN FLOW. THE CONSUMER STATED USING TWO DIFFERENT INSULIN PENS EACH DAY AND USES THE SAME NEEDLE FOR BOTH INJECTIONS. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE CLOG DURING INJECTION AND STATED THAT THERE IS NO INSULIN FLOW. THE CONSUMER STATED USING TWO DIFFERENT INSULIN PENS EACH DAY AND USES THE SAME NEEDLE FOR BOTH INJECTIONS. SAMPLES : AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648831 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown