BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM X 32G PEN NEEDLE (ULTRAFINE MICRO)

    MDR report key: 11468100 · Received March 11, 2021

    Report

    Report Number
    2243072-2021-00759
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 6MM X 32G PEN NEEDLE (ULTRAFINE MICRO) WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES NOT PRESSING OUT INSULIN. VERBATIM: CONSUMER REPORTED PEN NEEDLES NOT PRESSING OUT INSULIN CALLED THIS VOICE MESSAGE BACK LEFT 1ST MESSAGE" D.1. MEDICAL DEVICE BRAND NAME: 6MM X 32G PEN NEEDLE (ULTRAFINE MICRO) D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. (DUN LAOGHAIRE) D.4. MEDICAL DEVICE CATALOG#: 320749 D.4. UNIQUE IDENTIFIER (UDI) #: 00382903207497 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN D.4. MEDICAL DEVICE LOT #: 0140225 D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025 H.4. DEVICE MANUFACTURE DATE: 5/19/2020 D.4. MEDICAL DEVICE LOT #: 0253612 D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2025 H.4. DEVICE MANUFACTURE DATE: 9/9/2020 G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. (DUN LAOGHAIRE) G.5. PMA / 510(K)#: K162516 H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. LOT HISTORY REVIEWS WERE CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-24. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF 21 PEN NEEDLES. ALL SAMPLES WERE 6MM, 32 GAUGE AND THE INCLUDED TEARDROP LABELS IDENTIFIED THEM AS BEING FROM LOT 0253612. ALL PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING FOR NEEDLE CLOGS. 12 OF THE PEN NEEDLES WERE FOUND TO HAVE HAD THEIR NEEDLES BENT ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA, AND 2 WERE BROKEN ON THE SAME SIDE. THIS DAMAGE PREVENTS NORMAL TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACHING TO THE PEN. AS A RESULT, IT GIVES THE IMPRESSION THAT THE PEN NEEDLE IS CLOGGED WHEN USED. 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. THE REMAINING 7 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. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. BASED ON THE SAMPLES RECEIVED, BD FOUND THAT 12 PEN NEEDLES HAD BECOME BENT AND 2 HAD BEEN BROKEN ON THE NON-PATIENT SIDE, WHICH COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 6MM X 32G PEN NEEDLE (ULTRAFINE MICRO) WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES NOT PRESSING OUT INSULIN. VERBATIM: CONSUMER REPORTED PEN NEEDLES NOT PRESSING OUT INSULIN CALLED THIS VOICE MESSAGE BACK LEFT 1ST MESSAGE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 6MM X 32G PEN NEEDLE (ULTRAFINE MICRO) WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES NOT PRESSING OUT INSULIN. VERBATIM: CONSUMER REPORTED PEN NEEDLES NOT PRESSING OUT INSULIN CALLED THIS VOICE MESSAGE BACK LEFT 1ST MESSAGE."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES NOT PRESSING OUT INSULIN. VERBATIM: CONSUMER REPORTED PEN NEEDLES NOT PRESSING OUT INSULIN CALLED THIS VOICE MESSAGE BACK LEFT 1ST MESSAGE",

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355385 6MM X 32G PEN NEEDLE (ULTRAFINE MICRO) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1