BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 9284718 · Received November 6, 2019

    Report

    Report Number
    3003152976-2019-00765
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 14, 2019
    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: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTOS, THE BARREL IS OBSERVED TO BE DENTED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION BATCH 1907257. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO THE PRODUCT JAMMING IN THE MANUFACTURING EQUIPMENT. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE IS DEFORMED AND LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SYRINGE IS DEFORMED, THE PRODUCT IS NOT SEALED, AND THEREFORE, THERE WAS A LEAKAGE IN THE SYRINGE. 3 SYRINGES ARE AFFECTED. ALL OF THEM CONTAINED CHEMOTHERAPY. MYOCET (DOXORUBICINE).

    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 THE SYRINGE IS DEFORMED AND LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SYRINGE IS DEFORMED, THE PRODUCT IS NOT SEALED, AND THEREFORE, THERE WAS A LEAKAGE IN THE SYRINGE. 3 SYRINGES ARE AFFECTED. ALL OF THEM CONTAINED CHEMOTHERAPY. MYOCET (DOXORUBICINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077633 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1907257

    Patients

    Seq Age Sex Outcome Treatment
    1 Other