BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 11904965 · Received May 28, 2021

    Report

    Report Number
    9616066-2021-51207
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 10, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THERE WAS LEAKING IN THE TUBING, AND RETURNED THE AFFECTED SAMPLE. THE SAMPLE LEAKED FROM THE INLET OF THE UPPER FITMENT, AND THE COMPLAINT IS VERIFIED. WITH MINIMAL EFFORT, THE TUBING PULLED APART FROM THE BLUE CLIP. VISUAL ANALYSIS UNDER THE MICROSCOPE FOUND THE TUBING TO HAVE INSUFFICIENT SOLVENT. NO OTHER DEFECTS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 21026581 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 34,563 UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE IS DETERMINED TO BE INSUFFICIENT SOLVENT APPLIED TO THE TUBING AND BLUE CLIP CONNECTION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007; BATCH/LOT #: 21026581. I WOULD LIKE TO REPORT A LEAK NOTED ON (B)(6) 2021 FOR THE FOLLOWING PRODUCT. PRODUCT NAME: BD ALARIS PUMP INFUSION SET, BACK CHECK VALVE 3 SMART Y-SITES . NO REPORTED INJURY. FENTANYL BAG ATTACHED TO TUBING WAS EMPTY, BUT THERE SHOULD STILL HAVE BEEN REMAINING MEDICATION/FLUID INSIDE. NURSE NOTICED PUDDLE ON FLOOR AND TRACED IV LINE AND FOUND LEAKING SPOT IN THE TUBING.

    Additional Manufacturer Narrative · 1

    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 THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007. BATCH/LOT #: 21026581. I WOULD LIKE TO REPORT A LEAK NOTED ON 5/3/2021 FOR THE FOLLOWING PRODUCT. PRODUCT NAME: BD ALARIS PUMP INFUSION SET, BACK CHECK VALVE 3 SMART Y-SITES . NO REPORTED INJURY. FENTANYL BAG ATTACHED TO TUBING WAS EMPTY, BUT THERE SHOULD STILL HAVE BEEN REMAINING MEDICATION/FLUID INSIDE. NURSE NOTICED PUDDLE ON FLOOR AND TRACED IV LINE AND FOUND LEAKING SPOT IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798587 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21026581

    Patients

    Seq Age Sex Outcome Treatment
    1