BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 5341484 · Received January 4, 2016

    Report

    Report Number
    9610825-2015-00666
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 21, 2015
    Report Date
    December 21, 2015
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE EVALUATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT (B)(4). NO SAMPLE WAS RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE, LOT NUMBER AND ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. WITHOUT THE ACTUAL SAMPLE AND/OR LOT NUMBER, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF THE SAMPLE AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN INTERNAL REPORT NUMBER (B)(4). RECEIVED ONE USED CANNULA OF INTROCAN SAFETY WITHOUT PACKAGING THE SAFETY CLIP WAS NOT IN ENGAGED POSITION AND DISLODGED TO THE SIDE OF CANNULA. SAFETY CLIP WAS NOT DEFORMED. CATHETER HUB WAS NOT RETURNED FOR EVALUATION. SAMPLE EVALUATION: CANNULA OD AND CRIMP LENGTH MEASUREMENT FOR G20 THE RETURNED CANNULA OD IS 0.704MM AND IT WAS IDENTIFIED AS G20. CRIMP LENGTH MEASUREMENT IS WITHIN SPECIFICATION. THE RETURNED SAMPLE WAS CHECKED BY REPOSITIONING THE CLIP AND RETESTING ITS FUNCTION BY USING NEW CATHETER HUB (G20) AND PLACING IT ONTO THE CANNULA AND THEN PULLING IT AND FOUND THAT THE CLIP ENGAGED PROPERLY ONTO THE TIP OF THE CANNULA. THERE WAS NO ABNORMALITY FOUND WHILE PULLING THE CATHETER OUT FROM THE CANNULA. THE CLIP ENGAGED PROPERLY ONTO THE TIP OF THE CANNULA. THERE WAS NO ROUGH SURFACE/DENTED MARK OBSERVED ON CANNULA SURFACE. IN ADDITION, THE ASSEMBLY MACHINE IS ALSO EQUIPPED WITH A VISION SYSTEM WHICH CONDUCTS 100% INSPECTION ON THE CLIP CONDITION, IT IS UNLIKELY THAT THE DEFECT ESCAPE FROM PROCESS. CAUSE : CAUSE COULD NOT BE DETERMINE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS IT IS AN UNKNOWN BATCH NUMBER. JUSTIFICATION: NOT JUDGEABLE MULTIPLE ATTEMPTS TO OBTAIN ITEM, LOT NUMBER AND FURTHER INFORMATION WERE NOT SUCCESSFUL. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REF # UNKNOWN, BUT IS INTROCAN SAFETY, LOT # ALSO UNKNOWN. REPORTS CLIP DID NOT DEPLOY, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710 INTROCAN SAFETY I.V. SAFETY CATHETER DQR B.BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1