BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 12142289 · Received July 9, 2021

    Report

    Report Number
    9610825-2021-00271
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 21, 2021
    Report Date
    September 24, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 20D26G8371 AND THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLES EVALUATION: RECEIVED AN ADDITIONAL OF 100 PIECES OF INTROCAN SAFETY 3 PUR 24G 0.7X19MM-AP IN ORIGINAL PACKAGING. LOT NUMBER PRINTED ON RETURNED PEEL PACK ARE 20D26G8371 AND MATERIAL# 4251127-03. CLIP FUNCTION TEST: THE RETURNED 100 PCS OF UNUSED SAMPLES WERE TESTED AND THE RESULT SHOWED ALL PASSED. REFERENCE TO IFU: PLEASE KEEP IN MIND THE WRITTEN IFU THAT USER IS ADVISED TO WITHDRAW THE CANNULA BY PULLING CANNULA STRAIGHT BACK WITH A CONTROLLED, CONTINUOUS MOTION PARALLEL TO THE SKIN AND THE CANNULA IS ADVISABLE TO BE DISPOSED OF IMMEDIATELY INTO THE SHARPS CONTAINER. CONCLUSION: THE RETURNED 100 PCS SAMPLES FOUND NO DEVIATION ON THE SAFETY CLIP. COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 20D26G8371 AND THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. A FOLLOW-UP REPORT WILL BE PROVIDED, AS SOON AS INVESTIGATION HAS BEEN COMPLETED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4): NEEDLE STICK INJURY. "COMPLAINT: A NEEDLESTICK INJURY OCCURRED ON JUNE 21ST. SITUATION AT THE TIME OF OCCURRENCE: ON JUNE 21, IT WAS USED IN THE OUTPATIENT DEPARTMENT OF THE CHEMO ROOM. IT SEEMS THAT THE BLOOD VESSEL PUNCTURE AND THE REMOVAL OF THE INNER NEEDLE WERE PERFORMED AS USUAL (IT SEEMS THAT THERE WAS NO PARTICULAR RESISTANCE WHEN REMOVING THE INNER NEEDLE). IT SEEMS THAT THE NEEDLE TIP PROTRUDING FROM THE CLIP, AND THE CLINICIAN WAS STUCK WHEN THE REMOVED INNER NEEDLE WAS PLACED ON THE BEDSIDE OR ON THE DRAPE, AND WHEN IT WAS LIFTED IN THE FORM OF WRAPPING IT IN THE DRAPE AFTER SECURING THE BLOOD VESSEL." PATIENT USED: NO INFECTIOUS DISEASE. (AFTER THE NEEDLESTICK ACCIDENT, BLOOD WAS COLLECTED AND RE-EXAMINED JUST IN CASE, AND THE ITEM OF INFECTIOUS DISEASE WAS NEGATIVE.) THE INJURED NURSE COLLECTED BLOOD AND TESTED IT, AND THE ITEM OF INFECTIOUS DISEASE WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039882 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ 20D26G8371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other