BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10909330 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20455
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 1, 2020
    Report Date
    November 30, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY TWO SAMPLES OF MODEL 10014914 FOR QUALITY INVESTIGATION. THE CUSTOMERS COMPLAINT OF TUBING DEFECTIVE / DAMAGED WAS VERIFIED BY VISUAL INSPECTION. LARGE CRACKS FROM THE THREAD ENGAGEMENT PORTION OF THE LUER LOCK ADAPTER TO THE MIDDLE OF ITS BODY IS CLEARLY VISIBLE ON BOTH SAMPLES RECEIVED. FURTHER OBSERVATION SHOW NO ADDITIONAL DEFECTS OR DAMAGES. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10014914 BECAUSE A LOT NUMBER WAS NOT CONFIRMED BY THE CUSTOMER. THE ROOT CAUSE OF THE CRACKS SEEN IN THE SAMPLES SUBMITTED IS DUE TO OVER TIGHTENING OF THE LUER. THE LONGITUDINAL CRACKS FROM THE OPENING OF THE LUER TO THE MIDDLE OF THE BODY SUGGESTS THAT A TORQUE WAS APPLIED TO THE LUER CONNECTION THAN CAUSE THE LUER TO CRACK AT ITS ENGAGEMENT WITH THE FEMALE LUER CONNECTION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING LEAKED DURING USE AND A CRACK WAS FOUND IN THE FEMALE LUER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE TWO INCIDENTS OCCURRED ON TWO DIFFERENT PATIENTS WITH TWO DIFFERENT NURSES, ON THE SAME SHIFT. IN BOTH CASES, BEDSIDE RN NOTICED A PUDDLE ON FLOOR UNDER IV PUMP. UPON CLOSER EXAMINATION OF THE TUBING, A LONGITUDINAL CRACK WAS SEEN IN THE FEMALE LUER WHERE THE SYRINGE WAS ATTACHED. BOTH LINES WERE INTERMITTENT MEDICATION LINES. IN ONE, LASIX (BD 3 ML SYRINGE) AND PRE-FILLED NORMAL SALINE FLUSH (MONOJECT 3 ML SYRINGE) WERE GIVEN AND IN THE OTHER, A NEXUS TKO VALVE WAS ATTACHED. CEFEPIME AND NORMAL SALINE WERE THE ONLY FLUIDS TO GO THROUGH THIS LINE. THESE LINES ARE CHANGED EVERY 24 HOURS, SO THE TUBING HAD JUST BEEN HUNG THAT DAY. NO ALCOHOL OR OTHER CHEMICALS WERE USED ON THE LUER CONNECTOR, AND NO HEMOSTATS WERE USED. OUR STAFF ARE VERY COGNIZANT OF OVER TIGHTENING, AND DO NOT REPORT USING MORE THAN A MINIMAL AMOUNT OF TORQUE WHEN CONNECTING PIECES."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING LEAKED DURING USE AND A CRACK WAS FOUND IN THE FEMALE LUER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE TWO INCIDENTS OCCURRED ON TWO DIFFERENT PATIENTS WITH TWO DIFFERENT NURSES, ON THE SAME SHIFT. IN BOTH CASES, BEDSIDE RN NOTICED A PUDDLE ON FLOOR UNDER IV PUMP. UPON CLOSER EXAMINATION OF THE TUBING, A LONGITUDINAL CRACK WAS SEEN IN THE FEMALE LUER WHERE THE SYRINGE WAS ATTACHED. BOTH LINES WERE INTERMITTENT MEDICATION LINES. IN ONE, LASIX (BD 3 ML SYRINGE) AND PRE-FILLED NORMAL SALINE FLUSH (MONOJECT 3 ML SYRINGE) WERE GIVEN AND IN THE OTHER, A NEXUS TKO VALVE WAS ATTACHED. CEFEPIME AND NORMAL SALINE WERE THE ONLY FLUIDS TO GO THROUGH THIS LINE. THESE LINES ARE CHANGED EVERY 24 HOURS, SO THE TUBING HAD JUST BEEN HUNG THAT DAY. NO ALCOHOL OR OTHER CHEMICALS WERE USED ON THE LUER CONNECTOR, AND NO HEMOSTATS WERE USED. OUR STAFF ARE VERY COGNIZANT OF OVER TIGHTENING, AND DO NOT REPORT USING MORE THAN A MINIMAL AMOUNT OF TORQUE WHEN CONNECTING PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377573 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 UNKNOWN 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO