BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML BD PLASTIPAK SYRINGE LUER-LOK TIP

    MDR report key: 8913308 · Received August 20, 2019

    Report

    Report Number
    1213809-2019-00849
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS AND TEN 3ML SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 7120875 (P/N 309658) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL THE STOPPERS IN THE SYRINGES HAD SOME DEGREE OF STOPPER ANGULARITY. ALL TEN SYRINGES WERE MEASURED FOR STOPPER ANGULARITY USING A COMPARATOR. IN ALL CASES THE SYRINGES WERE ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER ANGULARITY DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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 STOPPER ANGULARITY OCCURRED BEFORE USE WITH A 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PREPARATION OF INJECTABLES, USING THIS LOT NUMBER, WE NOTICED THAT THE RUBBER STOPPER ON THE PISTON IS PLACED DIAGONALLY, WHICH HINDERS OR CAN FALSIFY THE ACCURATE READING OF THE CORRECT DOSE OF SMALL VOLUMES OF CYTOSTATICS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT STOPPER ANGULARITY OCCURRED BEFORE USE WITH A 3ML BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PREPARATION OF INJECTABLES, USING THIS LOT NUMBER, WE NOTICED THAT THE RUBBER STOPPER ON THE PISTON IS PLACED DIAGONALLY, WHICH HINDERS OR CAN FALSIFY THE ACCURATE READING OF THE CORRECT DOSE OF SMALL VOLUMES OF CYTOSTATICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707403 3ML BD PLASTIPAK SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7120875 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other