BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15026491 · Received July 15, 2022

    Report

    Report Number
    3003152976-2022-00321
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UG
    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE ALONG WITH ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DAMAGE OR OTHER DEFECTS WITHIN THE TIP WERE OBSERVED. TESTING WAS PERFORMED AND FOUND THE LUER FITTING MET REQUIRED SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2102037, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MOLDING PARAMETERS WERE REVIEWED FOR THE REPORTED LOT AND FOUND MACHINES WERE OPERATING WITHIN REQUIRED LIMITS. 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. ALL RESULTS WERE REVIEWED FOR LOT 2102037 AND NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. BASED ON THE SAMPLE EVALUATION AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY FAILURES RELATED TO THIS INCIDENT, WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER ADVANCES ITSELF (WITHOUT BEING PUSHED) PUSHING THE DRUG OUT THUS IT IS LEAKING THE DRUG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE 50CC LUER LOK SYRINGE IS LEAKING DRUG. THE PLUNGER ADVANCES ITSELF (WITHOUT BEING PUSHED) PUSHING THE DRUG OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER ADVANCES ITSELF (WITHOUT BEING PUSHED) PUSHING THE DRUG OUT THUS IT IS LEAKING THE DRUG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE 50CC LUER LOK SYRINGE IS LEAKING DRUG. THE PLUNGER ADVANCES ITSELF (WITHOUT BEING PUSHED) PUSHING THE DRUG OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722259 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown