BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE

    MDR report key: 17553229 · Received August 15, 2023

    Report

    Report Number
    1213809-2023-00868
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 2, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-SEP-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SYRINGE IS MISSING ALL ITS SCALE MARKINGS. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE SCALE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3082840. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT BEFORE USE, THE BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE WAS FOUND WITHOUT SCALE MARKINGS OR NUMBERS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE (1) X BD 5 ML SYRINGE LUER-LOK TIP (REF (B)(4) ) (LOT 3082840 EXP 2028-03-31) WAS ABSENT OF ALL MARKED INCREMENTS AND NUMBERS. NO PATIENT HARM. ESCALATED BEFORE 5 ML SYRINGE UTILIZED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE WAS FOUND WITHOUT SCALE MARKINGS OR NUMBERS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE (1) X BD 5 ML SYRINGE LUER-LOK TIP (REF 309646) (LOT 3082840 EXP 2028-03-31) WAS ABSENT OF ALL MARKED INCREMENTS AND NUMBERS. NO PATIENT HARM. ESCALATED BEFORE 5 ML SYRINGE UTILIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894346 BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3082840 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown