BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20DP CKV 2SS 117-IN 20PK

    MDR report key: 10358963 · Received August 3, 2020

    Report

    Report Number
    9616066-2020-02392
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203012430
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 07/21/2020. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THE CANNULA (IDENTIFIED AS MALE LUER) ATTACHED AT BOTTOM OF LINE POPPED OFF THE LINE WHICH WAS THEN OPEN AND CONTAMINATED. RECEIVED WAS A USED PARTIAL SET MODEL 2420-0500 LOT UNKNOWN. ALSO RECEIVED WERE THE CUSTOMER'S MEDICAL DEVICE INCIDENT OR PROBLEM MDIP REPORT FORM WITH DETAILS/NARRATIVE OF INCIDENT NOTED AS "UPON PRIMING LINES, WRITER NOTED THAT THE LUER LOCK? CANNULA ATTACHED AT BOTTOM OF LINE POPPED OFF THE LINE. THE LINE WAS THEN OPEN AND CONTAMINATED." AND NOTE WITH WRITTEN TEXT "SORRY SHE DID NOT KEEP THE PACKAGING SO WE CAN NOT TELL YOU LOT NUMBER". THE SET SAMPLE WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. THE EXPECTED MALE LUER P/N 600117 WAS NOT RECEIVED AND ATTACHED TO THE TUBING P/N TC10012940. NO OTHER ISSUE WAS OBSERVED. VISUAL INSPECTION UNDER MAGNIFICATION OF THE SEPARATED TUBING END OBSERVED NO SOLVENT TRACES. DIMENSIONAL ANALYSIS OF THE TUBING'S OUTER DIAMETER OBSERVED IT WAS WITHIN SPECIFICATION OF 0.145 ± 0.003 INCHES. EQUIPMENT USED (INSPECTION AND MEASUREMENT PERFORMED ON (B)(6) 2020): RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE (B)(6) 2021. THE DEVICE HISTORY RECORD FOR SET MODEL 2420-0500 COULD NOT BE CONDUCTED DUE TO NO LOT NUMBER BEING PROVIDED. THE CUSTOMER'S REPORT THAT THE MALE LUER DISCONNECTED FROM THE SET WAS CONFIRMED BASED ON VISUAL INSPECTION OF THE AS-RECEIVED SET SAMPLE. THE SEPARATION WAS AT THE ENGAGEMENT BETWEEN THE TUBING AND EXPECTED MALE LUER COMPONENTS. FURTHER VISUAL INSPECTION OF THE SEPARATED TUBING END IDENTIFIED THE ROOT CAUSE AS DUE TO INSUFFICIENT SOLVENT DUE TO EQUIPMENT AND/OR OPERATOR ERROR. DIMENSIONAL MEASUREMENT ALSO CONFIRMED THE TUBING TO BE WITHIN SPECIFICATION. BD MANUFACTURING FACILITIES ARE AWARE OF LACK OF ADHESIVE ON CRITICAL JOINTS. THE NOGALES FACILITY HAS INITIATED CORRECTIVE ACTIONS (CAPA 1027651) TO ADDRESS POTENTIAL ROOT CAUSES. NO LOT WAS PROVIDED FOR THE SET SAMPLE SO THE MANUFACTURE DATE WAS UNABLE TO BE IDENTIFIED IN RELATION TO THE CAPA IMPLEMENTATION DATE (B)(6)2020). THIS ISSUE WILL CONTINUE TO BE MONITORED FOR AN INCREASE IN FREQUENCY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20DP CKV 2SS 117-IN 20PK EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER: UPON PRIMING LINES, WRITER NOTED THAT THE LUER LOCK CANNULA ATTACHED AT BOTTOM OF LINE POPPED OFF THE LINE. THE LINE WAS THEN OPEN AND CONTAMINATED. NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20DP CKV 2SS 117-IN 20PK EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER: UPON PRIMING LINES, WRITER NOTED THAT THE LUER LOCK CANNULA ATTACHED AT BOTTOM OF LINE POPPED OFF THE LINE. THE LINE WAS THEN OPEN AND CONTAMINATED. NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821798 GEM V/NV 20DP CKV 2SS 117-IN 20PK INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203012430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200708| 20200708