BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G

    MDR report key: 9404731 · Received December 3, 2019

    Report

    Report Number
    9616656-2019-01190
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 15, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109, BATCH NO: 9121987. VERBATIM: ISSUE(S): FOUND 2 PEN NEEDLES STOPPED DURING INJECTION OF SAXENDA. LOT #: 9121987. ITEM #: 320109. DATE OF EVENT: (B)(6) 2019. SHE IS NEW TO INJECTIONS AND FOR ABOUT 1 AND 1/2 WEEKS. INFORMED PROPER PLACEMENT OF PEN NEEDLES AND TO COMPLETE FLOW CHECK.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109 BATCH NO: 9121987. VERBATIM: ISSUE(S): FOUND 2 PEN NEEDLES STOPPED DURING INJECTION OF SAXENDA. LOT #: 9121987. ITEM #: 320109. DATE OF EVENT: (B)(6) 2019. SHE IS NEW TO INJECTIONS AND FOR ABOUT 1 AND 1/2 WEEKS. INFORMED PROPER PLACEMENT OF PEN NEEDLES AND TO COMPLETE FLOW CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201868 BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 9121987 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other