BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 8592987 · Received May 8, 2019

    Report

    Report Number
    1213809-2019-00515
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A TOTAL OF 69 SEALED PACKAGED 5ML SYRINGES WERE RECEIVED, CONFIRMED TO BE FROM BATCH #9060905 (P/N 309646). THEY WERE VISUALLY EVALUATED. 67 SYRINGES HAD COMPLETELY BLANK BARRELS WITH NO PRINTED SCALE MARKINGS. 2 SYRINGES HAD FULLY PRINTED NORMAL SCALE MARKINGS WITH NO DEFECTS. MACHINE LOGS INDICATE MARKER ISSUES DURING PRODUCTION OF THIS BATCH. MARKER ADJUSTMENTS WERE RECORDED TO CORRECT ISSUES. FURTHERMORE, 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. POTENTIAL ROOT CAUSE FOR BLANK BARRELS IS LIKELY ASSOCIATED WITH MARKER ADJUSTMENTS DUE TO ISSUES FOUND DURING THE MARKING PROCESS. CORRECTIONS TOOK PLACE AT THE TIME ISSUES WERE DISCOVERED DURING THE MANUFACTURE OF THIS BATCH. IT IS POSSIBLE THAT DURING ADJUSTMENTS INCOMPLETE CONTAINMENT OF BLANK BARRELS ALLOWED A LIMITED NUMBER TO GET MIXED IN WITH THE GOOD PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKINGS ARE MISSING WITH A 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME OF THE SYRINGES ARE MISSING MEASUREMENT MARKINGS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCALE MARKINGS ARE MISSING WITH A 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME OF THE SYRINGES ARE MISSING MEASUREMENT MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386830 5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9060905 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other