BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16882261 · Received May 5, 2023

    Report

    Report Number
    3003152976-2023-00161
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 7, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 05-JUN-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, THE LUER THREAD IS BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2211030, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED 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 TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF AN OVER SCREW OF THE LUER LOCK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES THE THREAD OF THE DIFFUSER BROKE AND THE THREAD OF THE SYRINGE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: INCIDENT DESCRIPTION: DURING THE INJECTION INTO A CHEMOTHERAPY DIFFUSER OF A 1ST VOLUME OF 50 ML OF GLUCOSE 5% USING A 3-PIECE SYRINGE OF 60 ML LUER LOCK: RAS. THEN DURING THE INJECTION OF THE 2ND VOLUME OF 5% GLUCOSE: THE THREAD OF THE DIFFUSER BROKE AND THE THREAD OF THE SYRINGE CRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES THE THREAD OF THE DIFFUSER BROKE AND THE THREAD OF THE SYRINGE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: INCIDENT DESCRIPTION: DURING THE INJECTION INTO A CHEMOTHERAPY DIFFUSER OF A 1ST VOLUME OF 50 ML OF GLUCOSE 5% USING A 3-PIECE SYRINGE OF 60 ML LUER LOCK: RAS. THEN DURING THE INJECTION OF THE 2ND VOLUME OF 5% GLUCOSE: THE THREAD OF THE DIFFUSER BROKE AND THE THREAD OF THE SYRINGE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692065 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown