BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20729403 · Received November 19, 2024

    Report

    Report Number
    3002601200-2024-00635
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 28, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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#4080097 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 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:4022038, 3360806, 4022054- 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE TEST, PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST. THE TEST RESULTS SHOW THAT THEY ALL MEET THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 4. THE OCCURRENCE OF THE COMPLAINT MAY BE RELATED TO THE QUALITY OF THE PRODUCT, AND MAY ALSO BE RELATED TO THE PATIENT'S SKIN, VEIN CONDITIONS AND PUNCTURE METHOD. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE AND CATHETER, DO NOT WITHDRAW THE NEEDLE PREMATURELY, AND DO NOT MULTIPLE PUNCTURES. 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, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR RELEVANT TESTS, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE CATHETER BENT CANNOT BE DETERMINED.

    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

    1)KINDLY PROVIDE THE PHYSICAL/PICTURE/VIDEO SAMPLE IF AVAILABLE 2)WAS THERE ANY DELAY IN THE PATIENT TREATMENT? 3)DOES THE CATHETER WAS SEEN BENT BEFORE USE? 4)DOES THE CATHETER WAS PEELBACK DURING INSERTION? 1) NO SAMPLES OR PHOTOS PROVIDED 2) NO 3) NO 4) CATHETER ATROPHY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC CATHETER BENT ON (B)(6) 2024 WHILE ADMINISTERING A SHOT TO BED 83, HOSPITAL NUMBER (B)(6), THE INDWELLING NEEDLE HOSE WAS BENT, PREVENTING A SMOOTH INJECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314057 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4080097 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown