BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 6208669 · Received December 28, 2016

    Report

    Report Number
    9614279-2016-00215
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Report Date
    October 24, 2016
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT 3 B. BRAUN INC. INTERNAL REPORT # (B)(4). ONE USED CARESITE EXTENSION SET WITHOUT PACKAGING WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SET NOTED A VERTICAL CRACK ALONG THE LENGTH OF THE CARESITE FEMALE LUER THREADS. THE RETURNED SAMPLE CONFIRMED THE REPORTED INCIDENT OF LEAKING PRODUCT. INCIDENTS OF CRACKED/LEAKING VALVES CAN BE CAUSED BY MANY FACTORS, INCLUDING BUT NOT LIMITED TO THE PRODUCT BEING SUBJECTED TO AGGRESSIVE SOLVENTS/DRUGS, EXCESSIVE MECHANICAL STRESSES (OVER-TIGHTENING), OR OTHER VARIOUS UNFORESEEN CIRCUMSTANCES DURING THE CLINICAL APPLICATION. B. BRAUN MEDICAL INC. IS CONTINUING TO INVESTIGATE AND ADDRESS INCIDENTS INVOLVING CRACKING AND LEAKING OF THE CARESITE THROUGH (CAPA (B)(4)). IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 3. ANTIBIOTICS INFUSING FROM THE SIDE PUMP AND LEAKAGE OCCURRED. BLOOD HAD LEAKED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860266 CARESITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN DOMINICAN REPUBLIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1