BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 6208546 · Received December 28, 2016

    Report

    Report Number
    2523676-2016-00922
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 29, 2016
    Report Date
    November 30, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K140311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIRTY-TWO (32) TOTAL SAMPLES WERE RECEIVED FOR EVALUATION; EIGHT (8) IN OPEN PACKAGING. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. FIFTEEN (15) RANDOM SAMPLES WERE SUBJECTED TO A LEAKAGE TEST. LEAKAGE WAS NOTED FROM THE CRACKS ON TWELVE (12) OF THE SAMPLES. ALTHOUGH A DEFINITIVE CONCLUSION COULD NOT BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT, CRACKING OF THIS NATURE CAN OCCUR WHEN THE PRODUCT IS SUBJECTED TO AGGRESSIVE SOLVENTS/DRUGS, EXCESSIVE MECHANICAL STRESSES (OVER-TIGHTENING), OR OTHER VARIOUS UNFORESEEN CIRCUMSTANCES DURING THE CLINICAL APPLICATION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT 3 B. BRAUN MEDICAL INC. INTERNAL REPORT (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. NOTE: THIS CASE IS BEING FILED FOR CATALOG NUMBER 415126 WHICH IS A SET THAT IS ONLY SOLD IN (B)(6), HOWEVER THE SET CONTAINS A CARESITE COMPONENT WHICH IS SOLD IN THE US. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 3: CRACK AND LEAKAGE WERE FOUND DURING USE. DRUG USED: METHOTREXATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860566 CARESITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061431635

    Patients

    Seq Age Sex Outcome Treatment
    1