BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 11499866 · Received March 16, 2021

    Report

    Report Number
    9616656-2021-00270
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE PEN NEEDLES WITH NO INNER SHIELDS OR TEARDROP LABEL FOR IDENTIFICATION. ALL OF THE CANNULAS FOR THESE PEN NEEDLES HAVE BEEN BENT AT A SIGNIFICANT ANGLE AT THE BASE OF THE PATIENT END OF THE NEEDLE. THIS DAMAGE MAY HAVE OCCURRED IF FORCES PERPENDICULAR TO THE NEEDLE CANNULA WERE APPLIED ACCIDENTALLY DURING USE, RESULTING IN THE NEEDLE BENDING. ADDITIONALLY, EACH OF THESE PEN NEEDLES WAS ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE PASSED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE PEN NEEDLES DESPITE THEIR BENT CANNULAS. NO PROBLEMS WITH LEAKAGE WERE FOUND. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PEN NEEDLES BENDING DURING HER INJECTIONS. STATED ANOTHER TIME THE INSULIN CAME OUT DURING HER INJECTION AND WENT ONTO HER CLOTHING. LOT # 0133420. CAT # 320550. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PEN NEEDLES BENDING DURING HER INJECTIONS. STATED ANOTHER TIME THE INSULIN CAME OUT DURING HER INJECTION AND WENT ONTO HER CLOTHING. LOT # 0133420, CAT # 320550. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394985 PEN NDL 32G 4MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0133420 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1