BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9805726 · Received March 9, 2020

    Report

    Report Number
    3003152976-2020-00105
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 10, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1904352 , NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CYTOTOXIC MEDICATION LEAKED PAST THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "LEAKAGE AT THE PLUNGER (CYTOTOXIC). THE DRUG PASSED THROUGH THE PLUNGER AND THE BODY OF THE SYRINGE. SYRINGES USED FOR CHEMOTHERAPY."

    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 CYTOTOXIC MEDICATION LEAKED PAST THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "LEAKAGE AT THE PLUNGER (CYTOTOXIC). THE DRUG PASSED THROUGH THE PLUNGER AND THE BODY OF THE SYRINGE. SYRINGES USED FOR CHEMOTHERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267843 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1904352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other