BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 12481887 · Received September 16, 2021

    Report

    Report Number
    9614033-2021-00108
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE BOXES HAVE DIFFERENT PACKAGING AND THEY ARE TWO DIFFERENT SIZES WITH THE SAME REFERENCE NUMBER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER NAME AND ADDRESS: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1104797, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30 , DEVICE MANUFACTURE DATE: 2021-06-01. MEDICAL DEVICE LOT #: 1043500, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: 2021-03-30. 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 2 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE BOXES HAVE DIFFERENT PACKAGING AND THEY ARE TWO DIFFERENT SIZES WITH THE SAME REFERENCE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382008 BD 60ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 SEE H10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown