BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 29GA 12.7MM 100 BX 1200 USA

    MDR report key: 11530138 · Received March 19, 2021

    Report

    Report Number
    9616656-2021-00293
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903282036
    PMA / PMN Number
    K131358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 29GA 12.7MM 100 BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES BEND AND SOMETIMES BREAK DURING INJECTION. VERBATIM: CONSUMER REPORTED THAT THE NEEDLES BEND AND SOMETIMES BREAK DURING INJECTION. CONSUMER STATED THAT HE IS NOT SURE IF ANY OF THE NEEDLES BROKE OFF IN THE INJECTION SITE, HE STATED THAT IT COULD HAVE FALLEN ON THE FLOOR, TABLE, ETC. HE DID NOT SEEK MEDICAL ATTENTION. CONSUMER DOES NOT RE-USE. LOT #: 0112362. CATALOG #: 328203. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 29GA 12.7MM 100 BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES BEND AND SOMETIMES BREAK DURING INJECTION. VERBATIM: CONSUMER REPORTED THAT THE NEEDLES BEND AND SOMETIMES BREAK DURING INJECTION. CONSUMER STATED THAT HE IS NOT SURE IF ANY OF THE NEEDLES BROKE OFF IN THE INJECTION SITE, HE STATED THAT IT COULD HAVE FALLEN ON THE FLOOR, TABLE, ETC. HE DID NOT SEEK MEDICAL ATTENTION. CONSUMER DOES NOT RE-USE. LOT #: 0112362, CATALOG #: 328203, DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422293 PEN NDL 29GA 12.7MM 100 BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 328203 0112362 00382903282036

    Patients

    Seq Age Sex Outcome Treatment
    1