BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3-PIECE SYRINGE

    MDR report key: 13863838 · Received March 23, 2022

    Report

    Report Number
    3003152976-2022-00113
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 19-APR-2022. H.6. INVESTIGATION: NO SAMPLES FROM THE REPORTED LOT WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE SAMPLE FROM LOT 2112023 WAS PROVIDED. THROUGH VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE OBSERVED, THE LUER TIP WAS PROPERLY MOLDED AND NO BURRS WERE SEEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111091 AND PROVIDED LOT 2112023, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MOLDING PARAMETERS WERE REVIEWED AND VERIFIED TO BE WITHIN VALIDATED LIMITS. TEN RETAINED SAMPLES OF LOT 2111091 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGED OR OTHER DEFECTS WERE OBSERVED AND THE LUER THREADING WAS VERIFIED TO BE PROPERLY MOLDED. 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 PROCEDURE, INCLUDING TIP AND THREAD VERIFICATION. BOTH THE RETURNED SAMPLE OF LOT 2112023 AND RETAINED SAMPLES OF LOT 2111091 UNDERWENT THESE EVALUATIONS AND ALL DIMENSIONS WERE WITHIN SPECIFIED LIMITS, PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. BASED ON OUR QUALITY TEAMS INVESTIGATION, WE CANNOT IDENTIFY DEFINITIVE ROOT CAUSES AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PLASTIPAK¿ 3-PIECE SYRINGE, THE LUER TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES NOT SCREWING ON DIFFERENT DEVICES ALLOWING THE RECONSTITUTION OF CHEMOTHERAPIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PLASTIPAK¿ 3-PIECE SYRINGE, THE LUER TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES NOT SCREWING ON DIFFERENT DEVICES ALLOWING THE RECONSTITUTION OF CHEMOTHERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769046 BD PLASTIPAK¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown