BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 9245179 · Received October 28, 2019

    Report

    Report Number
    1213809-2019-01073
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 11, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE RE-SEALED SHELF CARTON, CONTAINING 1ML LL SYRINGES, WAS RECEIVED. BOTH, THE LABEL ON THE SHELF CARTON AND THE PRODUCT INSIDE, WERE CONFIRMED TO BE FROM BATCH #9150920 (P/N 309628). THE BLISTER PACKAGES WERE INDIVIDUALLY PACKED INSIDE THE SHELF CARTON. NO DEFECT WAS OBSERVED WITH THE PACKAGING OF THE PRODUCT. THIS PRODUCT IS MANUFACTURED ON MULTIPLE MANUFACTURING LINES, SOME OF WHICH ARE DESIGN TO PACKAGE IT IN INDIVIDUAL UNITS, WHILE OTHERS PACKAGE THE PRODUCT IN STRIPS OF FIVE. BOTH, STRIP OF FIVE AND INDIVIDUAL PACKAGE CONFIGURATIONS, ARE CORRECT PER PRODUCT SPECIFICATION. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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 BD 1ML SYRINGE LUER-LOK¿ TIP PACKAGE WAS DAMAGED. THIS OCCURRED ON 100 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE PACKAGES WERE ALREADY SEPARATED. WHEN CUSTOMER OPENED THE BOX, EACH SYRINGE PACK WAS ALREADY SEPARATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP PACKAGE WAS DAMAGED. THIS OCCURRED ON 100 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE PACKAGES WERE ALREADY SEPARATED. WHEN CUSTOMER OPENED THE BOX, EACH SYRINGE PACK WAS ALREADY SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042119 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9150920 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other