BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 16427477 · Received February 23, 2023

    Report

    Report Number
    1213809-2023-00112
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR 1213809-2023-00112 IS A DUPLICATE OF 2243072-2023-00226 THIS SUPPLEMENTAL IS TO CANCEL MDR 1213809-2023-00112.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ITEM HAS HAD MULTIPLE CUSTOMER COMPLAINTS FROM KAISER THAT THE ITEM 305916 IS DEFECTIVE. NO QA EVENT HAS BEEN ISSUED BUT MULTIPLE CIF¿S FOR MULTIPLE LOT NUMBERS. WE HAVE 12 PALLETS HERE THAT BD ISSUED AN RGA FOR BUT HAVE NOT PICKED UP AS WELL AS THE CUSTOMER HAS RETURNED ANOTHER 68CS PLUS 204BX WITH A NEW LOT NUMBER. QRA INITIATED A LOCAL HOLD FOR SEVERAL OF THE LOT NUMBERS BUT THEY HAVE NOT AUTHORIZED THE NEWEST LOT NUMBER THAT THE CUSTOMER FEELS ARE ALSO DEFECTIVE. PLEASE SEE IF YOU CAN ESCALATE THIS ISSUE. RELATED CASES BD PR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ITEM HAS HAD MULTIPLE CUSTOMER COMPLAINTS FROM (B)(6) THAT THE ITEM 305916 IS DEFECTIVE. NO QA EVENT HAS BEEN ISSUED BUT MULTIPLE CIF¿S FOR MULTIPLE LOT NUMBERS. WE HAVE 12 PALLETS HERE THAT BD ISSUED AN RGA FOR BUT HAVE NOT PICKED UP AS WELL AS THE CUSTOMER HAS RETURNED ANOTHER 68CS PLUS 204BX WITH A NEW LOT NUMBER. QRA INITIATED A LOCAL HOLD FOR SEVERAL OF THE LOT NUMBERS BUT THEY HAVE NOT AUTHORIZED THE NEWEST LOT NUMBER THAT THE CUSTOMER FEELS ARE ALSO DEFECTIVE. PLEASE SEE IF YOU CAN ESCALATE THIS ISSUE. RELATED CASES BD: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473854 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown