BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 16212653 · Received January 19, 2023

    Report

    Report Number
    3003152976-2023-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 28, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 14-FEB-2023 H6: INVESTIGATION SUMMARY THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO FOREIGN MATTER WAS OBSERVED. NO PARTICLES COULD BE IDENTIFIED WITHIN THE FLUID PATH AND THERE WAS NO EMBEDDED MATERIAL DETECTED WITHIN ANY OF THE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2012056, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN 3 BD PLASTIPAK¿ SYRINGES WHILE PREPARING INTRATHECAL METHOTREXATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WHEN PREPARING SYRINGES OF INTRATHECAL METHOTREXATE, THE PREPARERS OBSERVED PARTICLES IN THE BODY OF THE SYRINGE. THE PREPARATION WAS REPEATED 4 TIMES BEFORE A COMPLIANT SYRINGE WAS FOUND. CONSEQUENCES: INCREASED PREPARATION TIME. RISK OF CONTAMINATION OF THE SOLUTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN 3 BD PLASTIPAK¿ SYRINGES WHILE PREPARING INTRATHECAL METHOTREXATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WHEN PREPARING SYRINGES OF INTRATHECAL METHOTREXATE, THE PREPARERS OBSERVED PARTICLES IN THE BODY OF THE SYRINGE. THE PREPARATION WAS REPEATED 4 TIMES BEFORE A COMPLIANT SYRINGE WAS FOUND. CONSEQUENCES: INCREASED PREPARATION TIME. RISK OF CONTAMINATION OF THE SOLUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113711 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown