BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10133960 · Received June 9, 2020

    Report

    Report Number
    9616656-2020-00523
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION AND UNABLE OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, THE PATIENT END OF PEN NEEDLES ARE BENT, (NOTICING AFTER HE REMOVES THE PEN NEEDLE FROM INSULIN PEN) STATED, NO INSULIN FLOW WHEN TAKING INJECTION STATED, PEN NEEDLES ARE BENDING AT THE PATIENT END DURING INJECTION. MENTIONED, HE'S VERY FRUSTRATED WITH THE PRODUCT AND HE HAS NO CHOICE BUT TO USE IT BECAUSE HIS INSURANCE COMPANY WILL NOT APPROVE FOR A SECOND BRAND HE WOULD PREFER LOT: 9121994 CATALOG: 320122

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION AND UNABLE OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, THE PATIENT END OF PEN NEEDLES ARE BENT, (NOTICING AFTER HE REMOVES THE PEN NEEDLE FROM INSULIN PEN). STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, PEN NEEDLES ARE BENDING AT THE PATIENT END DURING INJECTION. MENTIONED, HE'S VERY FRUSTRATED WITH THE PRODUCT AND HE HAS NO CHOICE BUT TO USE IT BECAUSE HIS INSURANCE COMPANY WILL NOT APPROVE FOR A SECOND BRAND HE WOULD PREFER. LOT: 9121994. CATALOG: 320122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600132 BD ULTRA FINE PEN NEEDLES PISTON SYRINGE FMF BECTON DICKINSON AND CO. 320122 9121994 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other