BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 13423427 · Received February 2, 2022

    Report

    Report Number
    3014704491-2022-00049
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-20. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111451. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS RETURNED TO OUR FACILITY TO A SILICONE IS A MATERIAL USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. OUR ENGINEERS WERE UNABLE TO LOCATE ANY DAMAGE TO THE CATHETER TUBING, HOWEVER THEY DID IDENTIFY A PIECE OF EXTRANEOUS MATERIAL. COMPOSITIONAL TESTING OF THE EXTRANEOUS MATERIAL WAS ABLE TO POSITIVELY IDENTIFY IT AS SILICONE. SILICONE IS USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. EXCESS APPLICATION OF THE LUBRICANT IS CURRENTLY POSSIBLE DUE TO LIMITATIONS IN THE MANUFACTURING PROCESS. TO PREVENT FUTURE OCCURRENCES OF THE NATURE, OUR FACILITY HAS OPTIMIZED OUR LINE CHECKS TO IDENTIFY AND REMOVE EXCESS BUILD UP OF SILICONE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER PRN ADAPTER THE CATHETER WAS SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND THAT THE CATHETER TUBE SPLIT AND THE SPLIT PART FELL INTO THE SHIELD."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER PRN ADAPTER THE CATHETER WAS SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND THAT THE CATHETER TUBE SPLIT AND THE SPLIT PART FELL INTO THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259418 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown