BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 18060395 · Received November 2, 2023

    Report

    Report Number
    9616656-2023-01157
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 30, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT MDR # 9168991 WAS SENT IN ERROR. COMPLAINT CAPTURED UNDER REPORT MDR# 9230572 MFR#9616656-2023-01181. MFR#: 9616656-2023-01157 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT. VERBATIM: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT. DC LOT # UNKNOWN - FIRST BOX; LOT # 3017796 CURRENT BOX ; CATALOG# 320122 = 2 BOXES. FOLLOW UP FROM THE VERBATIM = LOT # UNKNOWN - FIRST BOX; LOT # 3017796 CURRENT BOX; CATALOG# 320122 = 2 BOXES; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD. HOPING THIS HELPS DC; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349001 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3017796 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown