BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 30X1/2 RB

    MDR report key: 9412132 · Received December 4, 2019

    Report

    Report Number
    1911916-2019-01275
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO WAS PROVIDED FOR EVALUATION. THE BATCH RECORD REVIEW WAS NOT PERFORMED AS IT COULD NOT BE LOCATED. HOWEVER, 3241369 AND 3241366 WERE FOUND. IT WAS CONFIRMED THAT AT THAT TIME THE EXPIRATION DATE WAS NOT PART OF THE REQUIREMENTS. 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 · 0

    IT HAS BEEN REPORTED THAT THE BD¿ NEEDLE 30X1/2 RB HAS BEEN FOUND MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE STERILITY WAS QUESTIONED FOR PRODUCT THAT DID NOT HAVE EXPIRATION DATES. VERBATIM: WE HAVE A NEED TO KNOW WHEN BD CHANGED AND STARTED LISTING EXPIRATION DATES ON STERILE PRODUCTS. WE HAVE SOME KITS THAT WERE BUILT WITH STERILE NEEDLES FROM 2010 TO 2017 THAT DID NOT HAVE EXPIRATION DATES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 HAS BEEN REPORTED THAT THE BD¿ NEEDLE 30X1/2 RB HAS BEEN FOUND MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE STERILITY WAS QUESTIONED FOR PRODUCT THAT DID NOT HAVE EXPIRATION DATES. VERBATIM: WE HAVE A NEED TO KNOW WHEN BD CHANGED AND STARTED LISTING EXPIRATION DATES ON STERILE PRODUCTS. WE HAVE SOME KITS THAT WERE BUILT WITH STERILE NEEDLES FROM 2010 TO 2017 THAT DID NOT HAVE EXPIRATION DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208848 BD¿ NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 305106 3241368 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other