BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE

    MDR report key: 13502046 · Received February 9, 2022

    Report

    Report Number
    3003152976-2022-00060
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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: 2022-MAR-08. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE PRODUCT, NO DAMAGE OR DEFECTS CAN BE OBSERVED IN THE THREADING OF THE SYRINGE, THREADING IS WELL FORMED AND THERE IS NO ISSUES NOTED WITHIN THE TIP. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110134, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS 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, INCLUDING TIP AND THREAD VERIFICATION TESTING. ALL RESULTS WERE REVIEWED FOR LOT 2110134 AND FOUND TO BE WITHIN SPECIFICATION. TESTING WAS ALSO PERFORMED ON THE RETURNED SAMPLE AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. 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 H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGES HAD THE SYRINGE AND MATING COMPONENT SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE IS NOT LOCKED IN THE EXTENSION HOSE, BUT ROTATES EMPTY, COMES OFF EXTREMELY EASILY. ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGES HAD THE SYRINGE AND MATING COMPONENT SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE IS NOT LOCKED IN THE EXTENSION HOSE, BUT ROTATES EMPTY, COMES OFF EXTREMELY EASILY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84241 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown