BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8760148 · Received July 3, 2019

    Report

    Report Number
    1213809-2019-00699
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND 48 LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTO AND PHYSICAL SAMPLES ALL THE SYRINGES WERE MISSING PRINT AT THE 3ML MARKING AND HAD A SCUFF MARK IN THE SAME LOCATION. SOME SYRINGES WERE MISSING THE ¿3¿ AND SOME WERE MISSING THE ¿ML¿. ALL SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS AND IS LIKELY DUE TO A JAMMED PIECE IN THE ASSEMBLY MACHINE THAT AFFECTED A NUMBER OF BARRELS THAT MOVED PASSED IT. THE DEFECT WOULD HAVE BEEN CREATED IN THE SAME LOCATION VERTICALLY ON THE BARRELS THAT WERE AFFECTED. CORRECTIONS TOOK PLACE AT THE TIME THE ISSUE WAS FOUND DURING THE MANUFACTURE OF THIS BATCH. IT IS LIKELY THE DEFECTIVE PRODUCT WAS NOT COMPLETELY CONTAINED AND GOT MIXED IN WITH THE GOOD PRODUCT. THE ISSUE IS CONSIDERED ISOLATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE THE SYRINGES ARE MISSING THE 3 ON THE BARREL FOR THE GRADUATION OF 3ML. THERE ARE 82 SYRINGES WHAT HAVE THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD SYRINGES THAT ARE MISSING THE 3 ON THE BARREL FOR THE GRADUATION OF 3ML. PART # 301073 LOT NUMBER 9031771.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE THE SYRINGES ARE MISSING THE 3 ON THE BARREL FOR THE GRADUATION OF 3ML. THERE ARE 82 SYRINGES WHAT HAVE THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD SYRINGES THAT ARE MISSING THE 3 ON THE BARREL FOR THE GRADUATION OF 3ML. PART # 301073, LOT NUMBER 9031771.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555135 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9031771 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other