BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL EURO 200 S/C

    MDR report key: 12450887 · Received September 9, 2021

    Report

    Report Number
    1213809-2021-00626
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: 2021-10-19. H6: INVESTIGATION SUMMARY FIVE 3ML SYRINGES (P/N 309658) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. TWO SYRINGES WERE LOOSE IN A BAG FROM UNKNOWN BATCH AND THREE WERE INSIDE PARTIALLY OPENED BLISTERPAKS FROM BATCH #0133148. THE TWO LOOSE SYRINGES WERE OBSERVED TO BE MISSING MUCH OF THEIR PRINT ALONG THE GRADUATED SCALE. ADDITIONALLY, ONE OF THE LOOSE SYRINGES HAD A LARGE INK SMEAR ON THE COLLAR WHICH WAS NON-CONFORMING PER PRODUCT SPECIFICATION. THE THREE SYRINGES INSIDE OF THE BLISTERPAKS DID NOT HAVE ANY VISIBLE DEFECTS. ALL SYRINGES APPEARED TO BE HEAVILY MANIPULATED. THE SAMPLES WERE ALSO TESTED FOR VOLUMETRIC ACCURACY PER INTERNAL PROCEDURE AND YIELDED ACCEPTABLE RESULTS PER PRODUCT SPECIFICATION. SINCE NO SAMPLES DISPLAYING THE VOLUMETRIC ACCURACY DEFECT WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. THE SAMPLES WERE HEAVILY MANIPULATED BEFORE BEING RETURNED TO THE MANUFACTURING SITE, THEREFORE THE MISSING PRINT COULD NOT BE CONFIRMED TO HAVE ORIGINATED FROM A MANUFACTURING RELATED PROCESS. POTENTIAL ROOT CAUSE FOR THE INK SMEAR DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. SINCE THE BATCH IS UNKNOWN FOR THE INK SMEAR DEFECT THE DEFECTIVE RATE COULD NOT BE IDENTIFIED, THEREFORE CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 0133148 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE SYRINGE 3ML LL EURO 200 S/C, THE DEVICE EXPERIENCED SCALE MARKING ISSUES. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER RETURNED THE SYRINGE DRIVER, 3X USED 3ML BD PLASTIPAK SYRINGES AND 3X NEW 3ML BD PLASTIPAK SYRINGES. I HAVE TESTED THE RETURNED SYRINGES WITH THE RETURNED SYRINGE PUMP AND ONE PUMP FROM CUSTOMER ADVOCACY STOCK. THE RESULTS THAT I GOT WERE QUITE SIMILAR FOR BOTH PUMPS. I LOADED ALL THE RETURNED SYRINGES ON CUSTOMER PUMP AND OUR PUMP. THE USED SYRINGES WERE SHOWING VALUES HIGHER OF THE 5% TOLERANCE; HOWEVER THE NEW SYRINGES WERE WITHIN THE 5%. IN ONE OCCASION WHICH HAPPENED FOR BOTH SYRINGE PUMPS, I LOADED ONE OF THE OLD SYRINGES IN THE PUMP, THE ACTUAL VOLUME IN THE SYRINGE WAS 2.9, ACCORDING TO THE MARKINGS ON THE SYRINGE. WHEN THE SYRINGE WAS LOADED IN THE PUMP, THE PUMP DISPLAYED 2.7ML. WITHOUT CHANGING THE POSITION ON THE PUMP.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE SYRINGE 3ML LL EURO 200 S/C, THE DEVICE EXPERIENCED SCALE MARKING ISSUES. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER RETURNED THE SYRINGE DRIVER, 3X USED 3ML BD PLASTIPAK SYRINGES AND 3X NEW 3ML BD PLASTIPAK SYRINGES. I HAVE TESTED THE RETURNED SYRINGES WITH THE RETURNED SYRINGE PUMP AND ONE PUMP FROM CUSTOMER ADVOCACY STOCK. THE RESULTS THAT I GOT WERE QUITE SIMILAR FOR BOTH PUMPS. I LOADED ALL THE RETURNED SYRINGES ON CUSTOMER PUMP AND OUR PUMP. THE USED SYRINGES WERE SHOWING VALUES HIGHER OF THE 5% TOLERANCE; HOWEVER THE NEW SYRINGES WERE WITHIN THE 5%. IN ONE OCCASION WHICH HAPPENED FOR BOTH SYRINGE PUMPS, I LOADED ONE OF THE OLD SYRINGES IN THE PUMP, THE ACTUAL VOLUME IN THE SYRINGE WAS 2.9, ACCORDING TO THE MARKINGS ON THE SYRINGE. WHEN THE SYRINGE WAS LOADED IN THE PUMP, THE PUMP DISPLAYED 2.7ML. WITHOUT CHANGING THE POSITION ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348301 SYRINGE 3ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 0133148 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown