BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 19782671 · Received July 19, 2024

    Report

    Report Number
    3002601200-2024-00330
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 15, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT 3353661 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JANUARY 2024 AND PACKAGED AT R240 PACKAGE LINE IN JANUARY 2024. WORK ORDER QUANTITY WAS (B)(4). 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. (MATERIAL NUMBER: B5171AAAL, BATCH NUMBER:3250291, 3250292, 3177666, 3206496, 3342227). 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN, AND THE CATHETER TIPPING IS EXAMINED UNDER THE MICROSCOPE. NO ABNORMALITY IS FOUND. PLEASE SEE ATTACHMENT PR#(B)(4) FOR THE PHOTO. PENETRATION FORCE TEST IS CARRIED OUT ON THE SAMPLE, AND THE CATHETER TIP FORCE IS WITHIN THE PRODUCT SPECIFICATIONS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE ROOT CAUSE OF THE ABNORMAL OF THE FRONT END OF THE CATHETER CANNOT BE DETERMINED DUE TO NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR FURTHER TESTING. THE PLANT WILL CONTINUE TO TRACK AND MONITOR SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AT 09:15 ON (B)(6) 2024, THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AS DIRECTED BY THE DOCTOR. IT WAS DIFFICULT TO FEED THE CATHETER DURING VENIPUNCTURE. AFTER PULLING IT OUT, IT WAS FOUND THAT THE FRONT END OF THE CATHETER WAS OBVIOUSLY BULGED AND DISCOUNTED. IMMEDIATELY OPEN THE NEW INDWELLING NEEDLE AGAIN AND FIND THAT THE FRONT END OF THE CATHETER IS DECOMPOSED AND AN OBVIOUS BULGE CAN BE PALPATED BY HAND. IMMEDIATELY ANALYZE AND COMFORT THE PATIENT, AND REPLACE THE INDWELLING NEEDLE PUNCTURE WITH ANOTHER MANUFACTURER'S. THE VENIPUNCTURE FAILED, WHICH INCREASED THE PATIENT'S PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER DEFECTIVE / DAMAGED. AT 09:15 ON (B)(6), 2024, THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AS DIRECTED BY THE DOCTOR. IT WAS DIFFICULT TO FEED THE CATHETER DURING VENIPUNCTURE. AFTER PULLING IT OUT, IT WAS FOUND THAT THE FRONT END OF THE CATHETER WAS OBVIOUSLY BULGED AND DISCOUNTED. IMMEDIATELY OPEN THE NEW INDWELLING NEEDLE AGAIN AND FIND THAT THE FRONT END OF THE CATHETER IS DECOMPOSED AND AN OBVIOUS BULGE CAN BE PALPATED BY HAND. IMMEDIATELY ANALYZE AND COMFORT THE PATIENT, AND REPLACE THE INDWELLING NEEDLE PUNCTURE WITH ANOTHER MANUFACTURER'S. THE VENIPUNCTURE FAILED, WHICH INCREASED THE PATIENT'S PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917746 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3353661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown