BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 14577448 · Received June 2, 2022

    Report

    Report Number
    9610825-2022-00209
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 19, 2022
    Report Date
    August 23, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    UDI-DI
    04046964478673
    PMA / PMN Number
    K982805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (B)(4). THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED, AS SOON AS INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). SAMPLE EVALUATION: RECEIVED 1 PIECE CAPILLARY HUB OF AN INTROCAN SAFETY 3 PUR 18G 1.3X32MM- AP WITHOUT ORIGINAL PACKAGING AND 44 PIECES OF INTROCAN SAFETY 3 PUR 18G 1.3X32MM-AP IN ORIGINAL PACKAGING WITH BATCH NUMBER 21G04G8373 AND ARTICLE NUMBER 4251131-03). VISUAL INSPECTION: RESULT: OBSERVED DAMAGE ON THE CATHETER HUB LUER FOR 9 PIECES OF UNUSED SAMPLE AND 1 PIECE OF USED SAMPLE. NO DAMAGE FOUND ON THE BALANCE 35 PIECES OF UNUSED SAMPLE IN ORIGINAL PACKAGING. LEAKAGE TEST: 10 PIECES OF SAMPLE WITH DAMAGE ON THE CATHETER HUB LUER WERE TESTED FOR AIR TIGHTNESS LEAKAGE TEST ACCORDING TO TEST METHOD. RESULT: ALL 10 PIECES OF SAMPLE PASSED THE TEST. ROOT CAUSE ANALYSIS: THE POSSIBLE CAUSE OF THE DENT LUER COULD BE DUE TO SLIGHT BEND OR SLANT SEPTUM OPENER PIN DURING THE ASSEMBLY OF CATHETER HUB TO CANNULA HUB. DURING SIMULATION, THE DEFECT WAS ABLE TO REPRODUCE. ANOTHER POSSIBLE CAUSE IS BIGGER OPENING OF SEPTUM OPENER PIN TOWARDS THE CATHETER HUB LUER AND DURING SIMULATION, THE DEFECT WAS ABLE TO REPRODUCE. CORRECTION: DAILY CHECKING FOR VALVE OPENER PIN CONDITION AT THE MACHINE AND TO RECORD IN PROCESS CARD. STARTED: 2022-05-12. ADDITIONAL CONTAINMENT ACTION TO REFER TO CAPA. THIS COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6). "AIR CAME IN FROM THE CONNECTION." "THERE WAS A REPORT THAT AIR WAS MIXED IN FROM THE INFUSION CONNECTION PART. IT OCCURRED IN AN OUTPATIENT AND EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL. IT OCCURRED IN 7 CONSECUTIVE CASES AFTER SWITCHING TO THIS LOT: 21G04G8373. WE WILL COLLECT AND SHIP ALL THE SAME LOT UNUSED PRODUCTS IN THE HOSPITAL INVENTORY. THE PATIENT HAS NO INFECTION / HEALTH HAZARD TO PATIENT: NONE . SAMPLE: AVAILABLE / BATCH: 21G04G8373 ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161397 INTROCAN SAFETY® I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG 4251601-020 21G04G8373 04046964478673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown