BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 10892003 · Received November 24, 2020

    Report

    Report Number
    1213809-2020-00828
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 28, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/14/2020. H.6. INVESTIGATION: ONE HUNDRED SIXTY-FIVE 5ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 0111797 (P/N 309649) WERE RECEIVED AND EVALUATED. ALL THE RETURNED SYRINGES WERE VISUALLY INSPECTED WITH NO DEFECTS OBSERVED. 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. THE DEFECT WAS NOT CONFIRMED, THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C HAD A CRACK AND LEAKED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED BARRELS LEADING TO LEAKAGE OF CYTOSTATIC DRUGS. TWO SEPARATE INCIDENTS: A NURSE EXPERIENCE A LEAKAGE WHILE ADMINISTRATING THE DRUG TO A PATIENT. WHEN THE SYRINGE IS EXAMINED A LARGE CRACK ALONG THE BARREL IS DISCOVERED. WHILE PREPARING THE SYRINGE WITH DRUGS, A PHARMACIST EXPERIENCE LEAKAGE AND UPON EXAMINATION OF THE PRODUCT, THE CRACKED BARREL IS DISCOVERED. BOTH DAMAGED PRODUCTS HAVE BEEN DESTROYED DUE TO THE USAGE OF CYTOSTATIC DRUGS.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C HAD A CRACK AND LEAKED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED BARRELS LEADING TO LEAKAGE OF CYTOSTATIC DRUGS. TWO SEPARATE INCIDENTS: A NURSE EXPERIENCE A LEAKAGE WHILE ADMINISTRATING THE DRUG TO A PATIENT. WHEN THE SYRINGE IS EXAMINED A LARGE CRACK ALONG THE BARREL IS DISCOVERED. WHILE PREPARING THE SYRINGE WITH DRUGS, A PHARMACIST EXPERIENCE LEAKAGE AND UPON EXAMINATION OF THE PRODUCT, THE CRACKED BARREL IS DISCOVERED. BOTH DAMAGED PRODUCTS HAVE BEEN DESTROYED DUE TO THE USAGE OF CYTOSTATIC DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359183 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 0111797 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1