BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8922123 · Received August 22, 2019

    Report

    Report Number
    9610847-2019-00531
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H. 6 INVESTIGATION: BASED ON DHR REVIEW FOR MATERIAL 383312 WITH LOT NUMBER 8212731, THE PRODUCT LOT MET THE PACKAGING SPECIFICATIONS AND QA INSPECTIONS; HOWEVER CUSTOMER DETECTED FOREIGN MATTER. BASED ON DEVELOPED INVESTIGATION, SAMPLE PROVIDED SHOWED FOREIGN MATTER IN THE NEEDLE TIP. SAMPLE WAS MAGNIFIED AND COULD NOTICED THAT THE FOREIGN MATTER FOUND IS SILICONE. AFTER ANALYZING THIS FOREIGN MATTER, THE TEAM CONCLUDES THAT THE FOREIGN MATTER DETECTED BY CUSTOMER IS SILICONE THAT IS APPLIED DURING THE MANUFACTURING PROCESS. SILICONE IS APPLIED TO THE FINISHED PRODUCT TO AID IN THE INSERTION OF THE DEVICE BY THE END USER. THE SILICONE USED IS A MEDICAL GRADE SILICONE. PROCESS FMEA 4797 AND P-EURA RM5942 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. BASED ON THE INVESTIGATION CONCLUSION THE CONDITION REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THE FOREIGN MATTER FOUND IN THE NEEDLE TIP IS SILICONE AND IT IS PART OF THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (CHINESE TRANSLATION). "NURSES IN THE OPENING OF PRODUCT PACKAGING FOUND THAT THE RETENTION NEEDLE TIP AREA HAS WOOL, THINK THAT THE CITY IS NOT STERILE PACKAGING, SO THE PRODUCT TO DO COMPLAINTS PROCESS, CUSTOMERS WANT TO KNOW WHY THE NEWLY OPENED PRODUCT PACKAGING NEEDLE TIP PART OF THE WOOL."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (CHINESE TRANSLATION). "NURSES IN THE OPENING OF PRODUCT PACKAGING FOUND THAT THE RETENTION NEEDLE TIP AREA HAS WOOL, THINK THAT THE CITY IS NOT STERILE PACKAGING, SO THE PRODUCT TO DO COMPLAINTS PROCESS, CUSTOMERS WANT TO KNOW WHY THE NEWLY OPENED PRODUCT PACKAGING NEEDLE TIP PART OF THE WOOL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716706 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212731 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other