BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 5101752 · Received September 24, 2015

    Report

    Report Number
    9610825-2015-00421
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 9, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE AND ALL AVAILABLE INFORMATION WERE FORWARDED TO THE MANUFACTURER FOR FURTHER EVALUATION. THEIR REPORT STATES THAT THEY RECEIVED ONE (1) INTROCAN SAFETY PUR 20G, 1.1X25MM-US WITHOUT PACKAGING. LOT NUMBER WAS REPORTED AS UNKNOWN. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE AND FOUND NO ABNORMALITIES. THE PROTECTIVE CAP AND CAPILLARY HUB WERE NOT RETURNED FOR INVESTIGATION. THE SAFETY CLIP WAS ACTIVATED AND ENGAGED AT THE TIP OF CANNULA. NO DEFORMATION WAS OBSERVED ON THE SAFETY CLIP. DURING FUNCTIONALITY TEST WITH A NEW CATHETER, THE SAFETY CLIP WAS ABLE TO ENGAGED AND COVERED THE CANNULA TIP. THE CLIP ENGAGED PROPERLY ONTO THE TIP OF THE CANNULA. THERE WAS NO ROUGH SURFACE/DENTED MARK OBSERVED ON CANNULA SURFACE. DEVICE HISTORY RECORD (DHR): REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED BECAUSE THE LOT NUMBER WAS REPORTED AS UNKNOWN. BASED ON THE RESULTS OF THE INVESTIGATION, NO SPECIFIC CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS: NEEDLESTICK INJURY WITH INTROCAN SAFETY IV CATHETER. "SHE STUCK HERSELF WITH THE EXPOSED TIP OF THE NEEDLE. SHE SAID THAT THE PART THAT COVERS THE NEEDLE HAD SLIPPED DOWN AND SHE STUCK HERSELF." AFTER SUCCESSFUL INSERTION OF CATHETER, NEEDLE WAS PLACED ON BED WHERE VENIPUNCTURE SUPPLIES WERE LOCATED. "NURSE PICKED UP NEEDLE FROM THE NEEDLE END, AND NOT THE HUB" TO DISCARD, THEN WAS STUCK IN THE LEFT INDEX FINGER. FACILITY BLOOD BORNE PATHOGEN PROTOCOL WAS FOLLOWED, PATIENT AND EMPLOYEE HAD BLOOD WORK PERFORMED, AT THIS TIME BLOOD WORK IS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630619 INTROCAN SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1