BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 19267929 · Received May 8, 2024

    Report

    Report Number
    9610825-2024-00333
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 9, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). 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 23B23G8241 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLES FOR EVALUATION: WE RECEIVED THE FOLLOWING SAMPLES:- - 2 (TWO) UNUSED AND IN ORIGINAL PACKAGING; - 1 (ONE) USED AND CONTAMINATED OF PRODUCT INTROCAN SAFETY FEP 20G, 1.1X45MM-AP. THE CANNULA HUB AND PROTECTIVE CAP WERE NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION: THE 2 (TWO) UNUSED SAMPLES IN ORIGINAL WERE INSPECTED AND NO DAMAGES WAS OBSERVED. THE 1 (ONE) USED WAS OBSERVED WITHOUT A CAPILLARY. NO BROKEN CAPILLARY RESIDUE OBSERVED AT METAL BUSH AREA. THE CAPILLARY OF THE USED COMPLAINT SAMPLE HAD COMPLETELY DETACHED FROM METAL BUSH. THE DETACHED CAPILLARY PIECE WAS NOT RETURNED FOR INVESTIGATION. THE INVESTIGATION ON THE COMPLAINT CAPILLARY SAMPLE WAS CONDUCTED BASED ON THE PHOTOS RECEIVED FROM CUSTOMER. PHOTOS FROM CUSTOMER: PHOTO 1 PRESENTS A B-ULTRASOUND IMAGE OF THE PATIENT'S HAND. THREE OPAQUE WHITE STRIPES WERE OBSERVED IN THE B-ULTRASOUND IMAGE. HOWEVER, IT IS NOT POSSIBLE TO DISTINGUISH WHICH STRIPE CORRESPONDS TO THE DETACHED CAPILLARY. PHOTO 2 INDICATES THAT A CONTAMINATED CATHETER HUB WAS CONNECTED TO AN EXTENSION LINE. THERE IS NO CAPILLARY OBSERVED ON THE CATHETER HUB. PHOTO 3 INDICATES THAT A DETACHED CONTAMINATED CAPILLARY HAD ELONGATED. OBSERVED PRESENCE OF WIDENING AREA AND BENDING OR TWISTING MARK AT CAPILLARY END. THE PRESENCE OF WIDENING AREA INDICATED THAT THE CAPILLARY HAD BEEN ASSEMBLED TO A METAL BUSH. UNABLE TO IDENTIFY THE LENGTH OF CAPILLARY WIDENING AND THE CONDITION OF THE CAPILLARY END DETACHMENT POINT. FUNCTIONAL TEST ON 2 UNUSED SAMPLES: THE UNUSED SAMPLES WERE SUBJECTED TO DYNAMIC TENSILE LOAD BETWEEN CATHETER (CAPILLARY) AND CATHETER (CAPILLARY) HUB (CATHETER STRENGTH TEST). RESULT: BOTH SAMPLES PASSED THE CAPILLARY STRENGTH TEST. AFTER THIS TEST, SAMPLES WERE INSPECTED AND BOTH REFERENCE SAMPLES CAPILLARIES WERE COMPLETELY DETACHED FROM THE METAL BUSH AFTER CATHETER STRENGTH TEST, WHICH ARE SIMILAR AS THE COMPLAINT SAMPLE. REVIEWED ASSEMBLY PROCESS: THE PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION SYSTEM AND TEST STATIONS. THE PROCESS CARDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITIES. ENGINEERING STUDY: AT ASSEMBLED CATHETER INTO CATHETER HUB STATION (DIGIFORCE STATION), THE ASSEMBLED METAL BUSH-CAPILLARY WILL BE ASSEMBLED INTO CATHETER HUB WITH PARALLEL SEQUENCE OF PUSHING THE METAL BUSH AND PULLING THE CAPILLARY. AN ENGINEERING STUDY WAS CONDUCTED TO IDENTIFY THE POTENTIAL ROOT CAUSE OF CAPILLARY DETACHMENT. FROM THE STUDY, IT CAN BE RULED OUT THAT THE TRANSFER CATHETER INTO CATHETER HUB STATION AND ASSEMBLED CATHETER INTO CATHETER HUB STATION COULD BE THE POTENTIAL ROOT CAUSE OF CAPILLARY DETACHMENT BECAUSE ALL SAMPLES PASSED THE CATHETER STRENGTH TEST. FROM THE ENGINEERING STUDY SAMPLES, OBSERVE SIMILAR DEFECT MODES OF CAPILLARY COMPLETELY DETACHED FROM METAL BUSH AS COMPLAINT SAMPLE AFTER CATHETER STRENGTH TEST. IT CAN BE CONCLUDED THAT EXCESSIVE FORCE EXERTED ON CAPILLARY COULD RESULT IN CAPILLARY DETACHMENT FROM CATHETER HUB EVEN THOUGH PASSED CATHETER STRENGTH TEST. HOWEVER, UNABLE TO RULE OUT THE POSSIBILITY OF EXCESSIVE FORCE BEING EXERTED ON CAPILLARY AT CUSTOMER END THAT CAUSING CAPILLARY DETACHMENT. DUE TO LACK OF THE COMPLAINT CAPILLARY SAMPLE, FURTHER INVESTIGATION WAS ONLY CARRIED OUT ON THE REFERENCE SAMPLES RECEIVED. THE CATHETER STRENGTH TESTS OF THE RETURNED REFERENCE SAMPLES WERE REPORTED AS PASSED.

    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 THE PATIENT SUFFERED FROM BREAST CANCER AND WAS HOSPITALIZED DUE TO PNEUMONIA. AT 7:00 A.M. ON (B)(6) 2024, THE PATIENT USED THE INDWELLING NEEDLE. AT 15:00 A.M. ON (B)(6) 2024, ABNORMALITIES WERE FOUND. REPORTEDLY AFTER B-ULTRASOUND, IT WAS FOUND THAT THE CAPILLARY WAS BROKEN IN THE BLOOD VESSEL, AND THEN THE VASCULAR SURGEON TOOK OUT THE BROKEN TUBE THROUGH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141361 INTROCAN SAFETY® IV CANNULAE FOZ B BRAUN MELSUNGEN AG 4252527-03 23B23G8241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention