BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 15331185 · Received August 31, 2022

    Report

    Report Number
    3003152976-2022-00391
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 26, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110020, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS, HOWEVER, A QUALITY NOTIFICATION WAS FOUND RELATED TO INCREASED INSPECTIONS THAT WERE PERFORMED DUE TO THE MARKING MACHINE RANDOMLY CAUSING DAMAGE TO THE BARREL. RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED ON ANY OF THE PRODUCTS. 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 LEAKAGE TESTING. THE RETAINED SAMPLES UNDERWENT THESE SAME EVALUATIONS AND NO ISSUES WERE IDENTIFIED, NO LEAKAGES WERE OBSERVED AND ALL PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. IT IS POSSIBLE THE LEAK REPORTED WAS DUE TO DAMAGE IN THE BARREL, WITHOUT THE PHYSICAL SAMPLE TO EVALUATE WE CANNOT VERIFY THIS TO BE TRUE FOR THE INCIDENT REPORTED. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY DEFINITIVE ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD ISSUES WITH EITHER WATER OR TSB LEAKING PAST THE PLUNGER WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT HAS BEEN NOTED BY 3 DIFFERENT PERSONNEL THAT WHEN DRAWING UP 10ML OF LIQUID (EITHER H20 OR TSB), THE SYRINGE HAS STARTED LEAKING DOWN THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD ISSUES WITH EITHER WATER OR TSB LEAKING PAST THE PLUNGER WHILE DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT HAS BEEN NOTED BY 3 DIFFERENT PERSONNEL THAT WHEN DRAWING UP 10ML OF LIQUID (EITHER H20 OR TSB), THE SYRINGE HAS STARTED LEAKING DOWN THE PLUNGER.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200643 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown