BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18194988 · Received November 22, 2023

    Report

    Report Number
    3014704491-2023-00751
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 17, 2023
    Report Date
    January 29, 2024
    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

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

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#3080063): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN (B)(6) 2023, AND PACKAGED AT CFS PACKAGE LINE IN (B)(6) 2023. 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. 2. NO ACTUAL SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR NEEDLE REMOVAL FORCE TEST, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS, PLEASE REFER TO THE ATTACHMENT PR#9151052-1 FOR THE TEST REPORT. NO SUBSTANCE SUCH AS PLASTIC SKIN FLAKES IS FOUND ON THE SURFACE OF THE NEEDLE UNDER MICROSCOPE, PLEASE REFER TO THE ATTACHMENT PR#9151052-2 FOR THE PHOTO . 4. POSSIBLE CAUSE: 1)ACCORDING TO INTIMA II PROCESS, PLASTIC SKIN FLAKES ON THE SURFACE OF THE NEEDLE MAY BE SILICONE, THE PRECIPITATE OF 1502C LUBRICANT. THE NEEDLE OF THE INTIMA II PRODUCT IS LUBRICATED WITH THE 1502C LUBRICANT THAT FORMS A DENSE LAYER ON THE SURFACE OF THE NEEDLE TO RELIEVE THE PATIENT'S PAIN DURING PUNCTURE. 2)THE SEPTUM POSITION WILL BE ADJUSTED AFTER LUBRICATION OF THE NEEDLE AT ZONE 4, SO THERE MAY BE RESIDUAL SILICONE BETWEEN THE NEEDLE AND THE SEPTUM.THE SILICONE CONDENSATE MAY MAKE IT DIFFICULT TO DISENGAGE THE NEEDLE AND THE SEPTUM. THE IFU OF THE PRODUCT INDICATES THAT BEFORE PUNCTURE, HOLD THE PADDLE HUB AND Y-ADAPTER, ROTATE THE PADDLE HUB TO RELEASE THE CATHETER TIP ADHESION, PLEASE REFER TO THE ATTACHMENT PR#9151052-3 FOR OPERATING VIEW. 3)BD'S MATERIALS LABORATORY IN THE UNITED STATES CONDUCTS A NORMATIVE TEST ON THE SILICONE USED IN THE PRODUCT PROCESS. THE TEST RESULTS SHOW THAT THE SILICONE IS A LUBRICANT FOR MEDICAL DEVICES AND MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. PLEASE REFER TO THE ATTACHMENT PR#9151052-4 AND PR#9151052-5. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT 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 ABOUT THIS BATCH OF PRODUCTS. SINCE THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO SUCH DEFECTS. H3 OTHER TEXT : SEE NARRATIVE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC NEEDLE DISENGAGEMENT DIFFICULT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; ON OCTOBER 17, 2023, A NURSE WAS USING A CLOSED IV INDWELLING NEEDLE WHILE ADMINISTERING IV FLUIDS TO A PATIENT AND COULD NOT REMOVE THE TROCAR WHEN PULLING IT OUTWARD AFTER A SUCCESSFUL PUNCTURE, AND AFTER ROTATING THE TROCAR FORCEFULLY TO PULL IT OUT, SHE NOTICED THAT THERE WERE PLASTIC SKIN FLAKES ON THE TROCAR ON TOP OF IT, WHICH WAS SUBSEQUENTLY REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990290 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080063 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown