BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 17839674 · Received September 28, 2023

    Report

    Report Number
    3014704491-2023-00611
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 23, 2023
    Report Date
    November 11, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#1218979): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2021, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2021. WORK ORDER QUANTITY WAS (B)(4) EA. 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)THE CANNULA BATCHES USED IN THIS BATCH OF PRODUCTS ARE 1090134, 1052930, 1052931, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE DEFECT STATUS CANNOT BE CONFIRMED. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT BATCH AND CHECK THE CANNULA UNDER THE MICROSCOPE. NO RUST IS FOUND. PLEASE SEE THE ATTACHED PHOTOS. 4. THE CANNULA IS MADE OF 304SS, WHICH HAS GOOD CORROSION RESISTANCE UNDER NORMAL CIRCUMSTANCES, BUT IN SPECIAL CIRCUMSTANCES, SUCH AS CONTAINING CHLORINE (OR SODIUM HYPOCHLORITE) AND OTHER CORROSIVE GASES, THE HEAD OF SOME CANNULAS MAY RUST. THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE SUCH DEFECT IN THE PRODUCTION PROCESS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE RETURNED, AND THE STORAGE ENVIRONMENT OF THE INDWELLING NEEDLE IS UNKNOWN, THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RUST WAS FOUND IN THE CORE OF THE BD INTIMA II¿ IV CATHETER PRN ADAPTER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 02:56 ON (B)(6) 2023, THE PREGNANT WOMAN ENTERED THE DELIVERY ROOM WITH HER CERVIX DILATED 3CM TO AWAIT DELIVERY. AT 03:30, DURING VENIPUNCTURE, RUST WAS FOUND ON THE CORE OF THE INDWELLING NEEDLE."

    Description of Event or Problem · 0

    AT 02:56 ON (B)(6), THE PREGNANT WOMAN ENTERED THE DELIVERY ROOM WITH HER CERVIX DILATED 3CM TO AWAIT DELIVERY. AT 03:30, DURING VENIPUNCTURE, RUST WAS FOUND ON THE CORE OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063356 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1218979 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 Female