BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SWITZERLAND SARL NOGALES

    MDR report key: 11009626 · Received December 15, 2020

    Report

    Report Number
    9616066-2020-20573
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 5, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203021020
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-24. H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED TUBING FELL APART AND RETURNED THE AFFECTED SAMPLE. THE AFFECTED SAMPLE CLEARLY SEPARATED AT THE OUTLET OF THE LOWER PUMP FITMENT, AND THE COMPLAINT WAS VERIFIED. DIMENSIONAL ANALYSIS SHOWED THAT THE BLUE CLIP AND TUBING WERE WITHIN TOLERANCE. ANALYSIS USING THE MICROSCOPE WAS DONE TO CHECK FOR TRACES OF SOLVENT, AND INSUFFICIENT TRACES WERE FOUND. THE BLUE CLIP WAS ANALYZED ALONG THE WHOLE INNER TUBE, AND JUST A SNAPSHOT WAS SHOWN AS IT TAKES FOCUSING IN AND OUT TO SEE THE WHOLE TUBE. THE ROOT CAUSE IS DETERMINED TO BE INSUFFICIENT SOLVENT. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 20083395. CAPA 1432807 HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 13 BD SWITZERLAND SARL NOGALES EXPERIENCED COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ON 13 ADDITIONAL OCCASIONS, THE TUBING IS DETACHING WHICH RESULTS IN LEAKAGE. VERBATIM: SEE BELOW, THIS INCIDENT HAS OCCURRED 13 ADDITIONAL TIMES! AS PER OUR DISCUSSION THE ITEM IS DETACHING. LOT #(10)20083395 THE DEPARTMENT SAYS IT HAS HAPPENED AT LEAST 11 TIMES, THIS IS IN THE CANCER CENTER AND CAN CAUSE A HAZARDOUS CONDITION. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 13 BD (B)(4) EXPERIENCED COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ON 13 ADDITIONAL OCCASIONS, THE TUBING IS DETACHING WHICH RESULTS IN LEAKAGE. VERBATIM: SEE BELOW, THIS INCIDENT HAS OCCURRED 13 ADDITIONAL TIMES! AS PER OUR DISCUSSION THE ITEM IS DETACHING. LOT #(10)20083395 THE DEPARTMENT SAYS IT HAS HAPPENED AT LEAST 11 TIMES, THIS IS IN THE CANCER CENTER AND CAN CAUSE A HAZARDOUS CONDITION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475891 BD SWITZERLAND SARL NOGALES INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2420-0007 20083395 37613203021020

    Patients

    Seq Age Sex Outcome Treatment
    1