BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN® SAFETY

    MDR report key: 5068284 · Received September 10, 2015

    Report

    Report Number
    9610825-2015-00387
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 18, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED ONE USED CAPILLARY HUB OF INTROCAN SAFETY-W PUR 24G, 0.7X19MM-AP WITHOUT PACKAGING. WE ALSO RECEIVED 5 INTROCAN SAFETY-W PUR 24G, 0.7X19MM-AP IN ORIGINAL PACKAGING. VISUALLY INSPECTED THE RETURNED CAPILLARY HUB AND FOUND THE CAPILLARY BROKEN OFF. THE SAMPLES AND ALL AVAILABLE INFORMATION WAS FORWARDED TO PRODUCTION FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING FINAL CONTROL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). STATEMENT FROM PRODUCTION: INSPECTION REPORT REVIEW: FROM THE INSPECTION REPORT OF BATCH 14N02G8364, NO ABNORMALITIES WERE OBSERVED, ESPECIALLY ON THE AIR TIGHTNESS TEST AND THE CAPILLARY TENSILE TEST, WHERE NO LEAKAGE WAS DETECTED AND THE CAPILLARY TENSILE IS RANGING FROM 12.96N - 16.97N (SPECIFICATION >3N). SAMPLE ANALYSIS: RECEIVED ONE USED CAPILLARY HUB OF INTROCAN G24X19 WITHOUT PACKAGING. THE CAPILLARY WAS BROKEN INTO TWO PARTS, WHERE APPROXIMATELY 3 MM OF CAPILLARY IS STILL INTACT WITH THE CATHETER HUB AND THE OTHER PART OF CAPILLARY IS BROKEN OFF. NO CANNULA AND PROTECTIVE CAP WERE RETURNED FOR INVESTIGATION. BESIDES THE USED SAMPLE, ALSO RECEIVED 5 PIECES OF INTROCAN SAFETY-W PUR 24G, 0.7X19MM-AP IN SEALED PACKAGING AND PRINTED WITH BATCH 14N02G8364. THE UNUSED SAMPLES SERVED AS THE REFERENCE SAMPLES. THE CAPILLARIES WERE INSPECTED UNDER SMARTSCOPE 39.1X MAGNIFICATION. THE CUT OFF AREA OF BOTH BROKEN PARTS WERE TO BE INSPECTED. OBSERVED THE CUT OFF ANGLE IS ABOUT 60° AT THE SIDE BUT IS FLAT ON THE FRONT AND BACK OF CATHETER THUMB AREA. SINCE THE CANNULA IS NOT RETURNED BY CUSTOMER, A NEW CANNULA WAS INSERTED TO STRAIGHTEN THE CAPILLARY AND TO CONNECT BOTH BROKEN PARTS. THE RETURNED CAPILLARY HUB WERE CONNECTED AND ASSEMBLED WITH A NEW CANNULA TO VERIFY THE TOTAL LENGTH OF THE BROKEN PIECES OF PRODUCT GAUGE (G24) AND LENGTH (19MM). A TRIM LENGTH DEFECT (MEASUREMENT BETWEEN CAPILLARY TIP TO THE BEVEL EYE) WITH EITHER LONGER OR SHORTER CAPILLARY WILL BE REJECTED BY ECM MACHINE. THE TRIM LENGTH OF THE RETURNED SAMPLE WAS MEASURED TO BE 0.2829MM, WHICH IS WITHIN THE ACCEPTABLE SPECIFICATION (0-0.40MM). REFERENCE SAMPLES VERIFICATION: THE 3 OF THE REFERENCE SAMPLES (OUT OF 5 SAMPLES) WERE SENT TO IN-PROCESS QUALITY CHECKING LABORATORY TO PERFORM THE SAMPLE ACCEPTANCE TEST. ADDITIONAL TEST WAS PERFORMED TO VERIFY THE CAPILLARY TENSILE TEST. REFERENCE SAMPLES TEST RESULT: NO ABNORMALITIES WERE DETECTED ON THE REFERENCE SAMPLES. OBSERVED CLEAN CUT ON THE BROKEN CAPILLARY BUT THE TRIM LENGTH WAS WITHIN THE ACCEPTANCE SPECIFICATION AFTER RE-CONNECT THE BROKEN PIECES. CONCLUSION: OBSERVED A CUT AT THE END OF THE BROKEN PARTS AND THE BROKEN CAPILLARY CAN BE MATCHED PERFECTLY WITH ACCEPTABLE TRIM LENGTH MEASUREMENT. NO ABNORMALITIES WERE DETECTED ON THE REFERENCE SAMPLES, ESPECIALLY ON THE LEAKAGE TEST AND CAPILLARY TENSILE STRENGTH TEST. THEREFORE, THE DEFECT IS NOT INDICATIVE TO MANUFACTURING FAILURE AND THIS COMPLAINT IS CONSIDER AS NOT JUDGEABLE. CORRECTIVE MEASURES HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA (B)(4). JUSTIFICATION: NOT JUDGEABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): THE DWELLING CATHETER BROKEN. PATIENT IS A (B)(6) OVERWEIGHT FEMALE WITH BODY WEIGHT (B)(6). ON (B)(6) 2015, WHEN THE PATIENT WENT TO TOILET AT ABOUT 9:40 A.M., SHE RANG THE ALARM BELL FOR HELP. NURSE FOUND THAT THERE WAS BLOOD ON HER LEFT WRIST WHERE IV CATHETER LOCATED. THE CATHETER HAD BROKEN AND THE DISTAL PART OF THE CATHETER WAS MISSING AND COULD NOT BE FOUND ON GROUND. SURGEON WAS INVITED FOR CONSULTANCY. AFTER CT EXAM, IMAGE FOUND A WHITE FOREIGN BODY ABOUT 1 CENTIMETER LONG NEAR HER LEFT THUMB. SURGEON PERFORMED OPERATION TO REMOVE THE BROKEN PART OF CATHETER BY INCISION OF SKIN. THE MISSING PART WAS REMOVED AT 5 P.M. AND THE PATIENT RECEIVED 3 STITCHES ON HER LEFT WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600694 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A 14N02G8364

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R