BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 13599521 · Received February 25, 2022

    Report

    Report Number
    9616656-2022-00230
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 3, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLES CLOGGED DURING INJECTION WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES. THIS HAS HAPPENED AT LEAST TWICE; HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 BOXES, SAME LOT - THEY CLOGGED DURING INJECTION WITH DIFFERENT PENS. CALLER DOES NOT COMPLETE FLOW CHECK AND WILL NOT COMPLETE FLOW CHECK SHE IS ALSO A NURSE. FEELS THE ONES WITH ISSUE HAD STRAIGHT NON PATIENT ENDS AT ALL TIMES. DISCARDED SAMPLES LOT # 1103587 - 2 BOXES . CATALOG# 320883 - 2 BOXES. DATE OF EVEN: UNKNOWN. HUSBAND INJECTS 5 TIMES A DAY JUST THESE 2 BOXES WITH ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLES CLOGGED DURING INJECTION WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES. THIS HAS HAPPENED AT LEAST TWICE; HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 BOXES, SAME LOT - THEY CLOGGED DURING INJECTION WITH DIFFERENT PENS. CALLER DOES NOT COMPLETE FLOW CHECK AND WILL NOT COMPLETE FLOW CHECK SHE IS ALSO A NURSE. FEELS THE ONES WITH ISSUE HAD STRAIGHT NON PATIENT ENDS AT ALL TIMES. DISCARDED SAMPLES . LOT # 1103587 - 2 BOXES . CATALOG# 320883 - 2 BOXES. DATE OF EVEN: UNKNOWN . HUSBAND INJECTS 5 TIMES A DAY JUST THESE 2 BOXES WITH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194959 BD NANO¿ ULTRA-FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1103587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown