BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21151953 · Received January 14, 2025

    Report

    Report Number
    3002601200-2024-00821
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT # 4171642. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN JULY 2024. 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 PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4149627, 4149630 AND 4173761, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TEST: SELF - TIGHTNESS TEST AFTER PENETRATION (I.E., THE SLEEVE STOPPER OF PRN IS PENETRATED 100 TIMES, AND THE LEAKAGE TEST IS PERFORMED AFTER THE PENETRATIONS). TEST RESULTS: NO LEAKAGE OR SWELLING OF SLEEVE STOPPER IS OBSERVED. 4. POSSIBLE REASONS FOR THE SWELLING OF THE SLEEVE STOPPER OF PRN: ABNORMAL RAW MATERIAL OF THE SLEEVE STOPPER, IMPROPER INSERTION OF THE SMALL END OF SLEEVE STOPPER INTO THE ADAPTER, DRY SURFACE OF THE INFUSION NEEDLE PIERCING INTO THE PRN, INJECTION PRESSURE GREATER THAN 45PSI, ETC. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE ROOT CAUSE OF THE SWELLING OF THE SLEEVE STOPPER OF THE PRN CANNOT BE DETERMINED AS NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, NO DEFECTIVE SAMPLE IS RECEIVED, AND THE USE OF THIS SAMPLE IS UNKNOWN. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75 IN PRN/EC SLM ADAPTER/CONNECTOR WAS DEFECTIVE/DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, A BRAIN SURGERY NURSE USED A CLOSED IV INDWELLING NEEDLE TO ADMINISTER AN INFUSION TO A PATIENT, ROUTINELY CHECKING THAT THE OUTER PACKAGING WAS NOT DAMAGED AND THAT THE SHELF LIFE WAS NORMAL BEFORE UNPACKING IT FOR USE.AT APPROXIMATELY 12:00 A.M. ON (B)(6), THE NURSE WAS PREPARING TO ADMINISTER AN INFUSION TO THE PATIENT, AND THE INSPECTION REVEALED THAT THE HEPARIN CAP HAD SWOLLEN AND BECOME TOO LARGE TO BE USED PROPERLY, AND THE IV NEEDLE WAS IMMEDIATELY REPLACED AND REINTRODUCED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516261 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171642 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown