BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL AMBER 14GA 1-1/4IN

    MDR report key: 8847220 · Received July 31, 2019

    Report

    Report Number
    3003152976-2019-00496
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 7, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 1812254, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1812254 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE SAMPLES WERE THEN CONNECTED TO A FRESENIUS INJECTOMAT MC AGILIA PUMP, NO ISSUES WERE IDENTIFIED AND NO ALARMING OCCURRED REGARDING THE SYRINGES RECOGNITION. 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. NO SAMPLE OR PICTURE HAS BEEN RECEIVED FOR INVESTIGATION. DHR OF LOT 1812254 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 50LL LOT 1812254 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE SAMPLES, NO DAMAGE OR MOLDING DEFECT CAN BE FOUND IN ANY OF THEM THAT COULD BE RELATED TO THE ALLEGED DEFECT. THESE TEN RETAINED SAMPLES ARE CONNECTED TO FRESENIUS INJECTOMAT MC AGILIA PUMP, NOT FINDING ANY ISSUE OR ALARM REGARDING SYRINGES RECOGNITION. THEY ARE CLAMPED AND THIS PUMP RECOGNIZES THEM AS 50ML LL PLASTIPAK SYRINGES NOT GIVING ANY ALARM. SINCE MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND NO MANUFACTURING DEFECT HAS BEEN FOUND IN RETAINED SAMPLES EVALUATED, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. SINCE NO DEFECT HAS BEEN FOUND IN RETAINED SAMPLES EVALUATED NO CORRECTIVE ACTION IS TAKEN. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE 50ML LL AMBER 14GA 1-1/4IN THE DIAMETER IS NOT IDENTICAL CAUSING A TECHNICAL ALARM TO GO OFF WHEN CLAMPED TO THE PERFUSOR PUMP. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE NAMED PRODUCT WILL BE DELIVERED TO THE STATIONS AS A REPLACEMENT FOR A PREDECESSOR MODEL THAT MEETS THE REQUIREMENTS WITHOUT CONSULTING. SINCE THE DIAMETERS ARE NOT IDENTICAL, THERE IS THE POSSIBILITY THAT THE PRODUCT IS NOT ALREADY DETECTED BY THE PERFUSOR PUMP WHEN IT IS BEING CLAMPED IN, AS WELL AS DURING OPERATION, WHICH RESULTS IN A TECHNICAL ALARM AND A DEVICE STANDSTILL. IN THE NIGHT SERVICE FROM (B)(6) 2019 IT COMES IN A POSTOPERATIVE PATIENTS, AS A RESULT OF WHICH AN INTERRUPTION OF CATECHOLAMINE THERAPY WITH THE FOLLOWING DROP IN BLOOD PRESSURE. THE SITUATION CAN BE CONTROLLED, THE PATIENT REMAINS UNSCATHED. " AFFECTED MEDICAL DEVICE: "BD PLASTIPAK", SN: (B)(6).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE 50ML LL AMBER 14GA 1-1/4IN THE DIAMETER IS NOT IDENTICAL CAUSING A TECHNICAL ALARM TO GO OFF WHEN CLAMPED TO THE PERFUSOR PUMP. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NAMED PRODUCT WILL BE DELIVERED TO THE STATIONS AS A REPLACEMENT FOR A PREDECESSOR MODEL THAT MEETS THE REQUIREMENTS WITHOUT CONSULTING. SINCE THE DIAMETERS ARE NOT IDENTICAL, THERE IS THE POSSIBILITY THAT THE PRODUCT IS NOT ALREADY DETECTED BY THE PERFUSOR PUMP WHEN IT IS BEING CLAMPED IN, AS WELL AS DURING OPERATION, WHICH RESULTS IN A TECHNICAL ALARM AND A DEVICE STANDSTILL. IN THE NIGHT SERVICE FROM (B)(6) 2019 TO (B)(6) 2019 IT COMES IN A POSTOPERATIVE PATIENTS, AS A RESULT OF WHICH AN INTERRUPTION OF CATECHOLAMINE THERAPY WITH THE FOLLOWING DROP IN BLOOD PRESSURE. THE SITUATION CAN BE CONTROLLED, THE PATIENT REMAINS UNSCATHED. " AFFECTED MEDICAL DEVICE: "BD PLASTIPAK", SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641384 SYRINGE 50ML LL AMBER 14GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1812254

    Patients

    Seq Age Sex Outcome Treatment
    1 Other