BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN

    MDR report key: 18080525 · Received November 6, 2023

    Report

    Report Number
    3014704491-2023-00716
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 8, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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

    1. THE CUSTOMER RETURNED (B)(4) ACTUAL SAMPLES, THE SKU IS (B)(4), THE BATCH CODE IS 2082643, ALL OF THE PACKAGES ARE UNOPENED. AMONG THEM, (B)(4) SAMPLES SHOW DIFFERENT DEGREES OF TOP WEB YELLOWING, SLEEVE STOPPER YELLOWING AND CRACKING, AND SOME NEEDLE TIPS RUSTED, WHILE THE OTHER (B)(4) SAMPLES SHOW NO ABNORMALITIES. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTOS. 2. DHR/BHR REVIEW(LOT#2082643): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN (B)(6) 2022, AND PACKAGED AT CFS PACKAGE LINE IN (B)(6) 2022. 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. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO ABNORMALITY IS FOUND. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTOS. 4. CAUSE ANALYSIS: 1) THE YELLOWING AND CRACKING OF SLEEVE STOPPER IS THE MANIFESTATION OF AGING, WHICH IS MAINLY CAUSED BY STRONG OXIDATION, INCLUDING: THERMAL OXYGEN AGING, LIGHT OXYGEN AGING, OZONE AGING (SUCH AS ENCOUNTERED OZONE DISINFECTION). 2) THERE ARE DIFFERENT DEGREES OF YELLOWING ON THE TOP WEB, AND SOME NEEDLE TIPS APPEAR RUSTY, WHICH ALSO INDICATES THAT THESE PRODUCTS HAVE ENCOUNTERED A POOR STORAGE ENVIRONMENT. THE NEEDLE OF THE INDWELLING NEEDLE IS MADE OF (B)(4) STAINLESS STEEL, WHICH HAS GOOD CORROSION RESISTANCE UNDER NORMAL CIRCUMSTANCES. 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 SAMPLES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED SAMPLES ARE EXAMINED AND IT IS DETERMINED THAT THE ROOT CAUSE OF YELLOWING AND CRACKING OF THE SLEEVE STOPPER ARE RELATED TO THE SUBSEQUENT TRANSPORTATION AND STORAGE OF THE PRODUCT, AND THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE SUCH DEFECTS IN THE PRODUCTION PROCESS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE HEPATOBILIARY SURGERY DEPARTMENT DISCOVERED THAT (B)(4) OF THE SAME BATCH OF INDWELLING NEEDLES HAD YELLOWED AND CRACKED ANTERIOR SEGMENT HEPARIN CAPS (B)(4) AFTER RECEIVING THE NEEDLES. SAMPLE EVALUATION: THE CUSTOMER RETURNED (B)(4), THE SKU IS (B)(4), THE BATCH CODE IS 2082643, ALL OF THE PACKAGES ARE UNOPENED. AMONG THEM, 5 SAMPLES SHOW DIFFERENT DEGREES OF TOP WEB YELLOWING, SLEEVE STOPPER YELLOWING AND CRACKING, AND SOME NEEDLE TIPS RUSTED, WHILE THE OTHER 6 SAMPLES SHOW NO ABNORMALITIES. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN HAD AN ADAPTER THAT WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THE HEPATOBILIARY SURGERY DEPARTMENT DISCOVERED THAT 11 OF THE SAME BATCH OF INDWELLING NEEDLES HAD YELLOWED AND CRACKED ANTERIOR SEGMENT HEPARIN CAPS (50/BOX) AFTER RECEIVING THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297465 BD INTIMA-II Y 24GAX0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2082643 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown