BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP DISPOSABLE SYRINGE

    MDR report key: 12283452 · Received August 5, 2021

    Report

    Report Number
    1213809-2021-00543
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    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

    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. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL LOT NUMBERS HAVE BEEN ADDED, AND THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE LEAKED WHEN CONNECTED WITH THE MAXZERO NEEDLESS CONNECTOR AND PIV. THIS OCCURRED ONCE EACH IN LOTS 1043505, 0298047, AND AN UNSPECIFIED LOT. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1043505. D.4. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. H.4. DEVICE MANUFACTURE DATE: 2021-04-06. D.4. MEDICAL DEVICE LOT #: 0298047. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. H.4. DEVICE MANUFACTURE DATE: 2020-12-02. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE 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." "WHAT¿S INTERESTING IS THAT WHEN WE TEST WITH A 10 ML SYRINGE, THE LEAKING STOPS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE LEAKED WHEN CONNECTED WITH THE MAXZERO NEEDLESS CONNECTOR AND PIV. THIS OCCURRED ONCE EACH IN LOTS 1043505, 0298047, AND AN UNSPECIFIED LOT. 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." "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. 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 THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE 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." "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
    1177864 BD LUER-LOK TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE SECTION H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1