BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 21209448 · Received January 22, 2025

    Report

    Report Number
    9610825-2024-01063
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 24, 2024
    Report Date
    February 28, 2025
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER XXXXXXXXX. 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. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 24H28G8952 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 (ONE) USED AND CONTAMINATED CAPILLARY HOUSING OF AN INTROCAN SAFETY 3 PUR 22G 0.9X25MM-EU, WITHOUT PACKAGING. CANNULA HUB AND PROTECTIVE CAP WERE NOT RETURNED FOR EVALUATION. VISUAL INSPECTION: FROM THE OBSERVATION AROUND ON THE RETURNED SAMPLE, THE TEAR OFF CAPILLARY AREA LOOKS SERRATED. REFERENCE TO THE INSTRUCTION FOR USE (IFU): AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: # DO NOT USE SCISSORS OR SHARP INSTRUMENTS AT OR NEAR THE INSERTION SITE. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS CATHETER INSPECTION STATION AND DEFECTIVE PARTS WILL BE DETECTED AND REJECTED BY MACHINES AUTOMATICALLY. THE ASSEMBLY PROCESS CARDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITY. MANUFACTURING CONTROL: BESIDES THE IN-LINE TEST EQUIPMENT, PRODUCTS ARE SUBJECTED TO IN-PROCESS QC AND FINAL CONTROL QC BASED ON RANDOM SAMPLES BASIS. REVIEWED THE INSPECTION RESULTS AND ALL TEST RESULTS WERE REPORTED AS PASSED, NO DAMAGE OR DEVIATION ON THE CAPILLARY FOR COMPLAINT BATCH 24H28G8952. CONCLUSION: BASED ON ABOVE INVESTIGATION AND SIMULATION, TEAR OFF CAPILLARY DEFECT IS NOT ATTRIBUTED TO MANUFACTURING PROCESS SINCE SUCH DEFECT WILL BE ABLE TO BE DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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 · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION: I AM WRITING TO INFORM YOU OF AN INCIDENT THAT OCCURRED ON WARD 21 INVOLVING A CANNULA. SPECIFICALLY, THE PLASTIC TUBING OF THE CANNULA HAD DETACHED FROM THE MAIN BODY OF THE VENFLON. THE CANNULA WAS INSERTED AT APPROXIMATELY 15:00. IT WAS SITED SECURELY, FLUSHED EFFECTIVELY, AND THE INITIAL DOSE OF IV ANTIBIOTICS (IVAB) ADMINISTERED IN THE EMERGENCY DEPARTMENT (ED) WENT THROUGH WITHOUT ANY ISSUES. HOWEVER, WHEN THE WARD ATTEMPTED TO ADMINISTER THE NEXT DOSE OF IVAB BETWEEN 02:00 AND 04:00, IT WAS DISCOVERED THAT THE TUBING HAD BECOME DETACHED. WE RAISED AS NO IMPACT WITH THE MHRA, BUT HAVE NOW BEEN ADVISED THE STAFF COULD NOT FIND THE TUBING, SO THE PATIENT IS HAVING SCANS IN CASE ITS INSIDE THE PATIENT - I WILL BE ABLE TO UPDATE AT A LATER DATE ON THIS. CLINICAL UPDATE: 1. TOO EARLY TO CONFIRM. THE PATIENT IS GOING FOR SCANS TODAY, TO SEE IF THE MISSING PART OF THE CANNULA SHOWS UP. THE NURSE SAID THEY'D INFORM ME OF THE RESULTS OF THIS. 2. THE PATIENT WAS TO HAVE ANOTHER DOSE OF I.V ANTIBIOTICS FIRST DOE PREVIOUSLY ADMINISTERED IN A&E), IT WAS AT THIS TIME WHEN THEY OPENED THE BANDAGE (PT IS 7YRS) THAT THE IV CANNULA WAS NOTED OUT OF THE PATIENTS SKIN, BUT WITH THE TUBING THAT SITS WITHIN THE VEIN TOTALLY MISSING. 3. THERE WAS A DELAY TO GET IV ANTIBIOTICS, AS THE EXISTING CANNULA COULDN'T BE USED AWAITING RESULT OF SCAN ON PATIENT TO DETERMINE PATIENT INJURY STATUS. INCIDENT DETAILS FROM MHRA FORM NATURE OF INCIDENT: THE CANNULA WAS INSERTED AT APPROXIMATELY 15:00 ON (B)(6) 2024. IT WAS SITED SECURELY, FLUSHED EFFECTIVELY, AND THE INITIAL DOSE OF IV ANTIBIOTICS (IVAB) ADMINISTERED IN THE EMERGENCY DEPARTMENT (ED) WENT THROUGH WITHOUT ANY ISSUES. HOWEVER, WHEN THE WARD ATTEMPTED TO ADMINISTER THE NEXT DOSE OF IVAB BETWEEN 02:00 AND 04:00 ON (B)(6) 2024, IT WAS DISCOVERED THAT THE TUBING HAD BECOME DETACHED. THE PLASTIC TUBING OF THE CANNULA (WHICH IS INSERTED INTO THE VEIN) DETACHED FROM THE MAIN BODY OF THE VENFLON. NURSE, INFORMED NURSE IN CHARGE AND REGISTRAR AND INCIDENT REPORT. A SAMPLE FROM THE BATCH WAS KEPT. NO OF PATIENTS INVOLVED 1 LOCATION OF SAMPLE DISCARD, HOWEVER INFORMED BY EMAIL THAT THE SAMPLE WAS KEPT. REMEDIAL ACTION TAKEN: INCIDENT REPORTED, TEAM ASKED TO BE VIGILANT USING DEVICES AND REPORT FURTHER ISSUES AND RETAIN DEVICE WHERE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650959 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MELSUNGEN AG 24H28G8952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown