BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 1-ML SYRINGE

    MDR report key: 15773246 · Received November 10, 2022

    Report

    Report Number
    1213809-2022-00936
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 17, 2022
    Report Date
    January 2, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 29-NOV-2022. INVESTIGATION SUMMARY: ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SYRINGE IS MISSING ALL THE NUMBERED PRINT SCALE MARKINGS ON THE LEFT SIDE OF THE GRADUATION LINES AND THE GRADUATION LINES ARE MISSING FROM THE ZERO LINE DOWN TO THE 0.4ML GRAD LINE. THE MISSING PRINT CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 9092992. A REVIEW SHOWED THAT THE SUB-ASSEMBLY PRODUCT HAD A QUALITY NOTIFICATION DURING THE PRODUCTION THAT CONTRIBUTED TO THE REPORTED DEFECT. A REQUALIFICATION WAS PERFORMED, AND THE LINE CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING WITHDRAWAL, THE OPERATOR NOTICED THAT THE MARKINGS ON THE SYRINGE WAS FADED, AND THE OPERATOR WAS UNABLE TO DETERMINE THE VOLUME OF SOLUTION THAT WAS DRAWN INTO THE SYRINGE

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING WITHDRAWAL, THE OPERATOR NOTICED THAT THE MARKINGS ON THE SYRINGE WAS FADED, AND THE OPERATOR WAS UNABLE TO DETERMINE THE VOLUME OF SOLUTION THAT WAS DRAWN INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773988 BD LUER-LOK¿ 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown