BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 100ML CATH TIP

    MDR report key: 17995943 · Received October 24, 2023

    Report

    Report Number
    3003152976-2023-00478
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 19, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903006052
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9100661 FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE STOPPER IS OBSERVED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER, THERE IS NO OTHER DAMAGE OR DEFECT IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2111150, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. 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. A VISION SYSTEM IS USED WITHIN THE ASSEMBLY MACHINE TO VERIFY PROPER ASSEMBLY OF THE STOPPER ON TO THE PLUNGER, REJECTING ANY MISSING OR MISASSEMBLED PRODUCTS. BASED ON THE SAMPLE EVALUATION AND GIVEN THE DEVICE RECORDS DID NOT INDICATE ANY ISSUE DURING MANUFACTURING, A ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0202 - DEFECTIVE COMPONENT. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    COMMENT FROM CUSTOMER( WE HAVE BEEN USING THESE SYRINGES FOR A VERY LONG TIME. FOR ABOUT HALF A YEAR WE HAVE THE PROBLEM THAT THE SYRINGES DO NOT SEAL PROPERLY / DRAW AIR. THAT IS, THE RUBBER ON THE PISTON IS TOO LOOSE ,OR THE SHELL OF THE SYRINGE TOO WIDE. ALREADY FROM 80-90 ML FILL LEVEL, IT IS ALMOST IMPOSSIBLE TO DRAW UP 100 ML OF LIQUID WITHOUT AIR BUBBLES, BECAUSE THE RUBBER DOES NOT SEAL OR THE LIQUID IN THE SYRINGE RUNS OUT THE BACK WHEN MOVING THE PISTON.

    Description of Event or Problem · 0

    COMMENT FROM CUSTOMRE( WE HAVE BEEN USING THESE SYRINGES FOR A VERY LONG TIME. FOR ABOUT HALF A YEAR WE HAVE THE PROBLEM THAT THE SYRINGES DO NOT SEAL PROPERLY / DRAW AIR. THAT IS, THE RUBBER ON THE PISTON IS TOO LOOSE ,OR THE SHELL OF THE SYRINGE TOO WIDE. ALREADY FROM 80-90 ML FILL LEVEL, IT IS ALMOST IMPOSSIBLE TO DRAW UP 100 ML OF LIQUID WITHOUT AIR BUBBLES, BECAUSE THE RUBBER DOES NOT SEAL OR THE LIQUID IN THE SYRINGE RUNS OUT THE BACK WHEN MOVING THE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157560 SYRINGE 100ML CATH TIP SYRINGE, PISTON FMF BECTON DICKINSON 2111150 00382903006052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown