BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 12283159 · Received August 5, 2021

    Report

    Report Number
    9614033-2021-00087
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 7, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE POTENTIAL LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THIS IS THE 2ND RELATED COMPLAINT FOR LEAKAGE OTHER ON THE POTENTIAL LOT NUMBERS 1043505, 0298047.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE EACH FROM LOTS 1043505 AND 0298047 LEAKED WHEN CONNECTED WITH THE MAXZERO NEEDLESS CONNECTOR AND PIV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE STARTED UP AGAIN WITH A TREND OF LEAKING MZ 1000-07¿S. THIS TIME ,WE ARE SEEING THE LEAKING OCCUR WHEN THE CLAVES ARE CONNECTED TO OUR 3 ML SYRINGES AND ARE BEING USED WITH PIV¿S NOT PICC¿S." "WHEN LEAKING OCCURS, WE ARE THEN UNCERTAIN IF ALL OF THE MEDICATION REACHED THE PATIENT. WHAT¿S INTERESTING IS THAT WHEN WE TEST WITH A 10 ML SYRINGE, THE LEAKING STOPS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1043505. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-04-06. MEDICAL DEVICE LOT #: 0298047. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-12-02. 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 · 1

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE EACH FROM LOTS 1043505 AND 0298047 LEAKED WHEN CONNECTED WITH THE MAXZERO NEEDLESS CONNECTOR AND PIV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE STARTED UP AGAIN WITH A TREND OF LEAKING MZ 1000-07¿S. THIS TIME ,WE ARE SEEING THE LEAKING OCCUR WHEN THE CLAVES ARE CONNECTED TO OUR 3 ML SYRINGES AND ARE BEING USED WITH PIV¿S NOT PICC¿S." "WHEN LEAKING OCCURS, WE ARE THEN UNCERTAIN IF ALL OF THE MEDICATION REACHED THE PATIENT. WHAT¿S INTERESTING IS THAT WHEN WE TEST WITH A 10 ML SYRINGE, THE LEAKING STOPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180116 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 SEE SECTION H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown