BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET, CLAVE Y-SITE, NON-DEHP TUBING, 0.2 MICRON FILTER,

    MDR report key: 20002433 · Received August 20, 2024

    Report

    Report Number
    9615050-2024-00620
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005971
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS UNKNOWN; 1 JUL 2024 HAS BEEN USED AS A PLACE HOLDER. D1 - BRAND NAME: PRIMARY PLUMSET, CLAVE Y-SITE, NON-DEHP TUBING, 0.2 MICRON FILTER, PE COATED TUBING, 104". INVESTIGATION SUMMARY: NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT OF LEAKAGE COULD NOT BE CONFIRMED BY INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    GCM RECEIVED AN EMAIL FROM MDPR / DIMM (HC/SC), GLOBAL REGULATORY AFFAIRS FORWARDING A COMPLAINT FROM MS. (B)(6) AT (B)(6) HOSPITAL ON 17 JULY 2024 ABOUT COMPLAINT WITH HEALTH CANADA REFERENCE NUMBER: 1105203. THE PRODUCT INVOLVED PRIMARY PLUMSET, CLAVE Y-SITE, NON-DEHP TUBING, 0.2 MICRON FILTER, PE COATED TUBING, 104",14255-28", WITH UNKNOWN ITEM NUMBER AND UNKNOWN LOT NUMBER. EXPIRY: 30 APRIL 2024. HEALTH CANADA DEVICE ID: 561981. THE PROBLEM WAS: THE PATIENT NOTICED THAT THERE WAS A LEAK (HAD 1 DROP ON HIS FINGER) IN CONNECTION WITH THE CHEMOTHERAPY INFUSER THAT WAS BEING INFUSED. THE MANUFACTURER IS ICU MEDICAL. RECEIPT DATE ON 4 JULY 2024, HEALTH CA LRN- 20240708-896. HEALTH CA RCT- 20240705-637. HOSPITAL REFERENCE # (B)(4). TERMS: A0504 - LEAK / SPLASH; E2401 - INSUFFICIENT INFORMATION; F05 - DELAY TO TREATMENT/THERAPY. THERE WAS A PATIENT INVOLVED, AND UNKNOWN PATIENT HARM. VHENNES 18 JULY 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531442 PRIMARY PLUMSET, CLAVE Y-SITE, NON-DEHP TUBING, 0.2 MICRON FILTER, SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. UNKNOWN 10887787005971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown