BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 11607443 · Received April 2, 2021

    Report

    Report Number
    9616066-2021-50645
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 24, 2021
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE - LEAK WAS VERIFIED THROUGH VISUAL INSPECTION AND TESTING. THE SAMPLE WAS VISUALLY INSPECTED AND A LARGE CRACK WAS IDENTIFIED ON THE FEMALE LUER ADAPTER. A SYRINGE WAS THEN CONNECTED TO THE SET AND LEAKAGE WAS IMMEDIATELY NOTICED WHEN PUSHING FLUID THROUGH THE SET. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10014914 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE FOR THIS FAILURE COULD NOT BE CLEARLY DETERMINED. THE PROBABLE CAUSE FOR THE LUER CRACKING IS AN EXCESSIVE AMOUNT OF FORCE USED TO CONNECT THE FEMALE LUER ADAPTER TO THE SYRINGE CAUSING IT TO CRACK. 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 · 1

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE LEAKED FROM A CRACK RUNNING DOWN THE CONNECTION PORT OF THE TUBING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF NOTICED FLUID ACCUMULATING AROUND THE CONNECTION BETWEEN THE MEDICATION SYRINGE AND TUBING A POOL OF STICKY LIQUID WAS ALSO NOTED TO BE ON THE FLOOR. ONCE THIS WAS DISCOVERED, A NEW PGE SYRINGE WAS OBTAINED FROM PHARMACY UPON CLOSER ASSESSMENT OF PREVIOUSLY HUNG SYRINGE AND TUBING, A LONG CRACK WAS SEEN RUNNING DOWN CONNECTION PORT OF TUBING WHICH WAS THE SOURCE OF THE LEAKING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PATIENT HAD A PICC LINE WITH MULTIPLE FLUIDS INFUSING, BUT THIS TUBING WAS ONLY CONNECTED TO ONE SYRINGE. THE CRACK ON THIS DEVICE WAS LOCATED ON THE DISTAL END OF THE TUBING, WHERE IT CONNECTS TO THE SYRINGE THAT IS LOADED INTO A SYRINGE PUMP IN THIS EVENT THE MEDICATION INFUSING FROM THE SYRINGE INTO THE TUBING WAS ALPROSTADIL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504881 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 1 MO