BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 19280422 · Received May 9, 2024

    Report

    Report Number
    9610825-2024-00339
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 10, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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. ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 23L05G8393 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 USED AND CONTAMINATED INTROCAN SAFETY PUR 20G, 1.1X32MM-AP WITHOUT PACKAGING. VISUAL INSPECTION: UPON VISUAL INSPECTION OBSERVED THAT THE CAPILLARY IS DAMAGED/TEAR OFF. THE TEAR OFF PIECE OF THE CAPILLARY WAS RETURNED FOR INVESTIGATION. THE LENGTH OF THE TEAR OFF PART WAS MEASURED AT 7MM. THE SAMPLE WAS TAKEN FOR INVESTIGATION AND OBSERVED THE CAPILLARY WAS TEAR APPROXIMATELY 25MM FROM THE CAPILLARY HORN AREA. THE TEAR OFF SURFACE IS CLEAN CUT AND ALSO EXHIBITS SOME FORM OF IRREGULARITY AT THE TORN EDGE OF THE CAPILLARY. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: -AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. DO NOT BEND THE CATHETER/NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. EXTREME CARE SHOULD BE TAKEN NOT TO CUT THE CATHETER AND POSSIBLY CAUSE AN EMBOLISM. IN THE CASE OF AN UNSUCCESSFUL IV START, REMOVE THE NEEDLE FIRST TO ACTIVATE SAFETY MECHANISM, THEN REMOVE CATHETER FROM PATIENT AND DISCARD BOTH. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION SYSTEM AND TEST STATIONS. ALONG THE MACHINE, THERE IS TRIM LENGTH, BEVEL AND CONTOUR CHECKING STATION. PARTS FOUND OUT OF THE INSPECTION CRITERIA WILL BE DETECTED AND REJECTED AUTOMATICALLY BY MACHINE. THE IN-LINE TEST EQUIPMENT IS SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN-TIME AND WOULD BE MITIGATED. THE PROCESS CARDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITY. CONCLUSION: THE TEAR-OFF CAPILLARY DEFECT IS UNLIKELY TO HAVE BEEN CAUSED BY THE MANUFACTURING PROCESS BECAUSE IT CAN BE DETECTED DURING THE INSPECTION PROCESS. IT IS IMPROBABLE THAT DAMAGES OCCURRED AFTER THE ASSEMBLY PROCESS, AS THE CATHETER WAS PROTECTED BY A PROTECTIVE CAP. THE COMPLAINT SAMPLES EXHIBITS SOME FORM OF IRREGULARITY AT THE TORN EDGE OF THE CAPILLARY WHICH BELIEVE TO BE CUT BY OTHERS SHARP INSTRUMENTS. THIS DEFECT IS NOT DUE TO MANUFACTURING PROCESS AND MOST LIKELY DUE TO APPLICATION ERROR. COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE 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 CUSTOMER A NURSE INFORMED THEY HEARD BROKEN SOUND WHILE INJECTION, WHEN THEY WITHDREW THE INTROCAN IT WAS FOUND THAT THE NEEDLE WAS SHORT AND BROKEN. THE PLASTIC TUBE WAS BROKEN IN PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331187 INTROCAN SAFETY® IV CANNULAE FOZ B BRAUN MELSUNGEN AG 4251644-03 23L05G8393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown