BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE

    MDR report key: 13309594 · Received January 20, 2022

    Report

    Report Number
    9616656-2022-00016
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 28, 2021
    Report Date
    April 15, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE MANUFACTURE DATE : UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 29-MAR-2022 D.4. MEDICAL DEVICE LOT #: 1048096 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026 H.4. DEVICE MANUFACTURE DATE: 17-FEB-2021 D.4. MEDICAL DEVICE LOT #: 1033648 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026 H.4. DEVICE MANUFACTURE DATE: 02-FEB-2021 D.4. MEDICAL DEVICE LOT #: 1110203 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026 H.4. DEVICE MANUFACTURE DATE: 20-APR-2021 D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF 29 USED 4MM, 32 GAUGE PEN NEEDLES. 10 TEARDROP LABELS WERE RETURNED IDENTIFYING SOME OF THEM AS BEING FROM LOTS 1048096, 1110203, AND 1033648. ALL OF THESE TEARDROP LABELS WERE OBSERVED TO BE LEGIBLE, FEATURING NO SMUDGING, OMISSIONS, OR OTHER DAMAGE THAT COULD RESULT IN IT BEING ILLEGIBLE. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING FOR CLOGS. 27 OF THE PEN NEEDLES WERE FOUND TO HAVE BENT NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. 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 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. THE REMAINING SAMPLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE REMAINING PEN NEEDLES. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLES. 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 27 PEN NEEDLES HAD BECOME BENT 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 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE WAS UNABLE TO PRIME AND HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE CLOG DURING PRIMING AND WAS NOT ABLE TO READ THE LOT # FROM THE TEAR DROP LABEL. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE WAS UNABLE TO PRIME AND HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE CLOG DURING PRIMING AND WAS NOT ABLE TO READ THE LOT # FROM THE TEAR DROP LABEL. DATE OF EVENT : UNKNOWN SAMPLES : AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506926 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown