BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10813065 · Received November 9, 2020

    Report

    Report Number
    9616656-2020-01105
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    October 15, 2020
    Report Date
    January 20, 2021
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES CANNULA BROKE OFF IN THE INJECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320109, BATCH NO: 8122794, UNKNOWN. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE INJECTION SITE DURING THE INJECTION. ALSO, THE NEEDLES BENT DURING THE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE BROKE OFF IN THE INJECTION SITE DURING INJECTION. HE DID NOT SEEK MEDICAL ATTENTION AND NEEDLE WAS NOT REMOVED. HE WANTED TO KNOW IF THE NEEDLE WOULD DISSOLVE AFTER TIME. ALSO REPORTED THAT IN PREVIOUS BOXES OF THE SAME PRODUCT, THE NEEDLES BENT DURING INJECTION. CONSUMER DID NOT PROVIDE LOT #, SAID IT WAS A LONG TIME AGO. CONSUMER ALSO REFUSED TO PROVIDE HIS MAILING ADDRESS AND REFUSED REPLACEMENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8122794. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-05-02. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES CANNULA BROKE OFF IN THE INJECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320109 BATCH NO: 8122794, UNKNOWN. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE INJECTION SITE DURING THE INJECTION. ALSO, THE NEEDLES BENT DURING THE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE BROKE OFF IN THE INJECTION SITE DURING INJECTION. HE DID NOT SEEK MEDICAL ATTENTION AND NEEDLE WAS NOT REMOVED. HE WANTED TO KNOW IF THE NEEDLE WOULD DISSOLVE AFTER TIME. ALSO REPORTED THAT IN PREVIOUS BOXES OF THE SAME PRODUCT, THE NEEDLES BENT DURING INJECTION. CONSUMER DID NOT PROVIDE LOT #, SAID IT WAS A LONG TIME AGO. CONSUMER ALSO REFUSED TO PROVIDE HIS MAILING ADDRESS AND REFUSED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272747 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 SEE H.10 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other