BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NON STERILE 50ML LL

    MDR report key: 10485857 · Received September 2, 2020

    Report

    Report Number
    3003152976-2020-00394
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 16, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811354, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. TESTING RESULTS WERE REVIEWED FOR LOT 1811354 AND ALL RESULTS WERE FOUND TO BE 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE NON STERILE 50ML LL PLUNGER MOVEMENT WAS DIFFICULT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED COMPLAINT REGARDING THE 50ML BD SYRINGE. COMPLAINT RECEIVED FROM OUR CUSTOMER RELATES TO THE SYRINGE BEING TO STIFF WHEN BEING USED WITH A SYRINGE DRIVER. NO MEDICATION WAS DELIVERED WHEN USED. I HAVE ASCERTAINED VIA OUR CUSTOMER ¿ THE PUMP USED WAS AN ALARIS PLUS WHICH IS SPECIALLY CONFIGURED FOR HIGH RISK INFUSIONS MEANING IT WILL TOLERATE A HIGHER PRESSURE THAN NORMALLY USED ON THE WARDS, THE LINE IS A STANDARD LINE FOR SYRINGE PUMPS WHICH IS USED IN ALL AREAS ACROSS THE TRUST.¿ THIS ISSUE HAS BEEN FOUND IN 2 SYRINGE UNITS. THE CUSTOMER WAS UNABLE TO PROVIDE ANY SAMPLES OF THE UNITS FOUND TO BE DEFECTIVE DUE TO BOTH UNITS BEING FILLED WITH DRUG PRIOR TO INSERTION INTO SYRINGE DRIVER SO THE COULD NOT CONFIDENTLY COMPLETE DECONTAMINATION FORM, BOTH UNITS AND DRUG CONTAINED WITHIN THEM HAVE BEEN DISPOSED OF AT COST TO OUR CUSTOMER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE NON STERILE 50 ML LL PLUNGER MOVEMENT WAS DIFFICULT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED COMPLAINT REGARDING THE 50 ML BD SYRINGE. COMPLAINT RECEIVED FROM OUR CUSTOMER RELATES TO THE SYRINGE BEING TO STIFF WHEN BEING USED WITH A SYRINGE DRIVER. NO MEDICATION WAS DELIVERED WHEN USED. I HAVE ASCERTAINED VIA OUR CUSTOMER, ¿THE PUMP USED WAS AN ALARIS PLUS WHICH IS SPECIALLY CONFIGURED FOR HIGH RISK INFUSIONS MEANING IT WILL TOLERATE A HIGHER PRESSURE THAN NORMALLY USED ON THE WARDS, THE LINE IS A STANDARD LINE FOR SYRINGE PUMPS WHICH IS USED IN ALL AREAS ACROSS THE TRUST.¿ THIS ISSUE HAS BEEN FOUND IN 2 SYRINGE UNITS. THE CUSTOMER WAS UNABLE TO PROVIDE ANY SAMPLES OF THE UNITS FOUND TO BE DEFECTIVE DUE TO BOTH UNITS BEING FILLED WITH DRUG PRIOR TO INSERTION INTO SYRINGE DRIVER SO THE COULD NOT CONFIDENTLY COMPLETE DECONTAMINATION FORM, BOTH UNITS AND DRUG CONTAINED WITHIN THEM HAVE BEEN DISPOSED OF AT COST TO OUR CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949956 SYRINGE NON STERILE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1811354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other