BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9483555 · Received December 17, 2019

    Report

    Report Number
    3003152976-2019-00863
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 28, 2019
    Report Date
    January 14, 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

    H.6. INVESTIGATION: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE THREAD OF THE BARREL IS OBSERVED TO BE CRACKED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1910214 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FINAL PRODUCTS FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE THREAD BECAME DAMAGED WITHIN THE MANUFACTURING EQUIPMENT. A PROJECT WAS INITIATED TO LOOK FURTHER INTO THIS AND REDUCE ANY REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACKED LUER WAS FOUND WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING A CYTOTOXIC RECONSTITUTION: WHEN MY 5FU WAS INJECTED INTO THE DIFFUSER, THE 50ML SYRINGE DETACHED ITSELF FROM THE DIFFUSER. WHEN I CHECKED THE PROBLEM, I NOTICED THAT THE LUER LOCK TIP WAS CRACKED AND THIS CAUSED THE CYTOTOXIC TO LEAK."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). 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 A CRACKED LUER WAS FOUND WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING A CYTOTOXIC RECONSTITUTION: WHEN MY 5FU WAS INJECTED INTO THE DIFFUSER, THE 50ML SYRINGE DETACHED ITSELF FROM THE DIFFUSER. WHEN I CHECKED THE PROBLEM, I NOTICED THAT THE LUER LOCK TIP WAS CRACKED AND THIS CAUSED THE CYTOTOXIC TO LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280108 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1910214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other