BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 12444591 · Received September 9, 2021

    Report

    Report Number
    2243072-2021-02265
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    July 17, 2021
    Report Date
    August 26, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED (B)(4) AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE WAS DAMAGED, BUT STILL OPERABLE "IT WAS REPORTED THE SYRINGE BROKE. " CTS ADDED NEEDLE/SYRINGE ISSUE CASE ISSUE TO THIS CASE (B)(4) NEEDLE/SYRINGE ISSUE: CALLER ESTIMATED EVENT DATE TO TO A FEW WEEKS AGO, CTS ESTIMATED EVENT DATE AS (B)(6) 2021 CALLER REPORTED [THE SYRINGE BROKE]. NUMBER OF OCCURRENCES - [1]. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. WAS THE SYRINGE/NEEDLE REUSED? - NO . PRODUCT WITH ISSUE - BD 26 G, 3/8"" NEEDLE, PN 305110. PRODUCT LOT # - [0022962]. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. CTS SENT REPLACEMENT NEEDLE/ CARTRIDGE. NO FURTHER TANDEM FOLLOW UP IS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342714 UNSPECIFIED BD NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR