BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRM/C60/N35

    MDR report key: 8636890 · Received May 23, 2019

    Report

    Report Number
    2243072-2019-01003
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    April 22, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FRN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    JFRL WAS PROVIDED WITH SAMPLES FOR CATALOG 515511-ZAT TO INVESTIGATE FOR THIS RECORD. AFTER PERFORMING A FLOW TEST, JFRL WAS NOT ABLE TO VERIFY THE REPORTED ISSUE. NO OCCLUSION ON THE RETURNED SAMPLE WAS DISCOVERED. LOT# IS UNKNOWN SO A DHR COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLOW ISSUES OCCURRED WITH A PRM/C60/N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONNECTED 515511-ZAT TO TERUMO CHEMO SAFE INFUSION SET AND C45 TO THE SURE PLUG. THEN FLOWED CABAZITAXEL ACETONATE(CHEMO). HOWEVER ALL THE DRUG DIDN'T DRIP."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ATOM. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 FLOW ISSUES OCCURRED WITH A PRM/C60/N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONNECTED 515511-ZAT TO TERUMO CHEMO SAFE INFUSION SET AND C45 TO THE SURE PLUG. THEN FLOWED CABAZITAXEL ACETONATE (CHEMO). HOWEVER ALL THE DRUG DIDN'T DRIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432440 PRM/C60/N35 INFUSION DEVICE FRN BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other