BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 6169282 · Received December 13, 2016

    Report

    Report Number
    9610825-2016-00888
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    November 29, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046963185206
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). INVESTIGATION RESULTS: RECEIVED ONE USED (CONTAMINATED WITH BLOOD) CANNULA HUB OF INTROCAN SAFETY PUR 20G, 1.1X25MM-US IN AN OPENED PACKAGING. THE CAPILLARY HUB AND PROTECTIVE CAP WERE NOT RETURNED FOR INVESTIGATION. VISUALLY INSPECTED THE RETURNED SAMPLE AND OBSERVED THE SAFETY CLIP WAS LOCATED IN THE MIDDLE OF THE CANNULA, NOT IN AN ENGAGED POSITION. FOR FUNCTIONAL TEST, THE SAFETY CLIP WAS REPOSITIONED AND A NEW G20 CATHETER HUB WAS PLACED ONTO THE CANNULA. UPON WITHDRAWAL, THE CLIP WAS ABLE TO ENGAGE AND COVERED THE TIP OF THE CANNULA. THERE WAS NO ROUGH SURFACE/DENTED MARK OBSERVED ON CANNULA SURFACE. CLIP WAS NOT DEFORMED. THE ASSEMBLY MACHINE IS EQUIPPED WITH VISION SYSTEM WHICH CONDUCTS 100% INSPECTION ON THE CLIP CONDITION. THEREFORE, IT IS UNLIKELY A DEFECTIVE CLIP CAN ESCAPE THE PROCESS. THE CATHETER HUB WAS NOT RETURNED FOR FURTHER EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING FINAL CONTROL INSPECTION. THE CAUSE OF THE REPORTED DEFECT COULD NOT DETERMINED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE RE-OPENED AND A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED SAFETY CLIP DID NOT DEPLOY CORRECTLY TO COVER NEEDLE TIP WHEN REMOVED FROM CATHETER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820133 INTROCAN SAFETY® I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG 16D16G8391 04046963185206

    Patients

    Seq Age Sex Outcome Treatment
    1