BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY

    MDR report key: 16954795 · Received May 18, 2023

    Report

    Report Number
    9610847-2023-00119
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 19, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 9610847-2023-00119 WAS AN INCORRECT ENTRY THERE WAS NO MIX PRODUCT, THIS SUPPLEMENTAL IS TO CANCEL MDR 9610847-2023-00119. MFR#: 9610847-2023-00119 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN. AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2094401. D4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2027. H4. DEVICE MANUFACTURE DATE: 09MAY2022. D4. MEDICAL DEVICE LOT #: 2094410. D4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2027. H4. DEVICE MANUFACTURE DATE:09MAY2022. D4. MEDICAL DEVICE LOT #: 2119471. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAR2027. H4. DEVICE MANUFACTURE DATE:26MAY2022. D4. MEDICAL DEVICE LOT #: 2153045. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAR2027. H4. DEVICE MANUFACTURE DATE: 20JUN2022. D4. MEDICAL DEVICE LOT #: 2153047. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAR2027. H4. DEVICE MANUFACTURE DATE: 12JUL2022. D4. MEDICAL DEVICE LOT #: 2171751. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2027. H4. DEVICE MANUFACTURE DATE: 19JUL2022. D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY THERE WAS A MIXTURE OF PRODUCTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SOMETIMES WE FOUND CARDBOARD PIECES, BLACK PARTICLES, FIBERS LIKE THREADS, BLANK SYRINGES, B PLUNGERS INSIDE AND ETC.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY THERE WAS A MIXTURE OF PRODUCTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SOMETIMES WE FOUND CARDBOARD PIECES, BLACK PARTICLES, FIBERS LIKE THREADS, BLANK SYRINGES, B PLUNGERS INSIDE AND ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893797 BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309703 SEE H.10 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown