BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 6131449 · Received November 29, 2016

    Report

    Report Number
    9610825-2016-00723
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Report Date
    November 11, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). 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 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). MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE AND ADDITIONAL INFORMATION. NO SAMPLE WAS RETURNED FOR EVALUATION; BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: "HAD A SERIOUS PROBLEM WITH INTROCAN SAFETY CATHETERS 20G AND 24G. THE NEEDLE SPLIT FROM THE SHEATH INSIDE THE PATIENT'S VEIN. CLINICALLY THE INFUSION SITE WAS PAINFUL AND LASTED 2 DAYS." "ISSUE OCCURRED ON INSERTION. EXPLAINED CATHETER SEPARATED AROUND THE NEEDLE ON INSERTION. PATIENT DID COMPLAIN OF PAIN DURING INSERTION REMOVED FROM PATIENT AND NOTED CATHETER WAS SPLIT. NO INTERVENTION NEEDED ON EITHER PATIENT. REPORTS HE WAS NOT PERSON WHO DID CATHETER INSERTION SO HE IS UNSURE IF THAT PERSON DID OR DID NOT MOVE THE NEEDLE OUT A BIT AND BACK IN SEARCHING FOR THE VEIN. CUSTOMER DID SAVE THE 24 GAUGE CATHETER AS SAMPLE, BUT NOT THE 20 GAUGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783120 INTROCAN SAFETY® I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other