BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 6287653 · Received January 30, 2017

    Report

    Report Number
    9610825-2017-00012
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Report Date
    January 16, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    UDI-DI
    04046963166274
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). 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.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 EVENT 3: B. BRAUN MEDICAL INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4) MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE AND ADDITIONAL INFORMATION. ALTHOUGH A SAMPLE WAS NOT RECEIVED, ALL AVAILABLE INFORMATION WAS FORWARDED TO THE MANUFACTURER. BASED ON THE MANUFACTURER'S STATEMENT, NO ROOT CAUSE COULD BE DETERMINED WITHOUT THE ACTUAL SAMPLE TO EVALUATE. THEREFORE, THE REPORTED COMPLAINT WAS NOT CONFIRMED. PROCESS EVALUATION FOR THE REPORTED ARTICLE NUMBER 4251601-02 AND BATCH NUMBER 16F01G8318 WAS PERFORMED TO THE EXTENT POSSIBLE. RECORDS SHOW THAT FROM 2013 TO JANUARY 2017, THE STERILIZATION PROCESS, BIOLOGICAL INDICATOR AND CYTOTOXICITY STUDY, ALL APPEAR TO SUPPORT THE CONCLUSION THAT THE MANUFACTURING PROCESS OF THE DEVICE DOES NOT CONTRIBUTE TO SKIN REACTIONS/INFLAMMATION. HOWEVER, IF THE SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS, "HAS HAD PATIENTS OVER THE LAST 2 MONTHS WHO HAVE HAD PHLEBITIS AT INSERTION SITE. ALL HAVE DIAGNOSIS OF CHRONIC REGIONAL PAIN SYNDROME. ALL COMPLAINED OF BURNING WHEN DRUG ADMINISTERED, PHLEBITIS NOTED AT SITE ANYWHERE FROM 5 HOURS TO 3 DAYS OF DWELL TIME. PHLEBITIS SYMPTOMS ANYTHING FROM SMALL RED SWOLLEN AT INSERTION SITE TO RED STREAK UP VEIN. REPORTS ALL WERE TREATED WITH AND RESPONDED WELL TO AMOXICILLIN, NO OTHER INTERVENTION REQUIRED. ALL ARE ATTENDING KETAMINE CLINIC FOR PAIN, ALL RECEIVING DRUG, ALL HAVE SAME SITE PREP AND DRESSING. ALL IV'S STARTED BY SAME NURSE. REPORTS MOST OF THESE PATIENTS DID NOT HAVE HISTORIES OF SKIN REACTIONS TO DIFFERENT PRODUCTS OR MANY ALLERGIES. CUSTOMER REPORTS 10 EVENTS; HOWEVER, IT IS UNKNOWN IF THE UNITS WERE MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392 OR MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318, SO THE COMPLAINT UNITS WERE SPLIT EVENLY BETWEEN TWO PIRS: 400330840: MATERIAL NUMBER 4252500-02/BATCH NUMBER 16C16G8392: 5 COMPLAINT UNITS; 400330974: MATERIAL NUMBER 4251601-02/BATCH NUMBER 16F01G8318: 5 COMPLAINT UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70491 INTROCAN SAFETY® I.V. SAFETY CATHETER DYB B. BRAUN MELSUNGEN AG 16F01G8318 04046963166274

    Patients

    Seq Age Sex Outcome Treatment
    1