BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 10135679 · Received June 9, 2020

    Report

    Report Number
    8041187-2020-00329
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THERE ARE NO SAMPLES OR PHOTOGRAPHS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. HOWEVER THE INVESTIGATION TEAM HAS THE RETENTION SAMPLES OF LOT NO 9253437 AVAILABLE FOR INVESTIGATING THE REPORTED DEFECT. SINCE NO SAMPLE HAS REACHED US YET (ON 20DAYS) SO THE INVESTIGATION IS PERFORMED ON THE RETENTION SAMPLES OF LOT NUMBER 9253437 OF THE MATERIAL CODE 393202 THAT IS AVAILABLE FOR INVESTIGATION. THE RETENTION SAMPLES DID NOT HAVE ANY DEFECT IS THE LENGTH OF CATHETER WITH RESPECT TO THE NEEDLE LENGTH DEFECT FOUND IN THEM. THE DHR WAS REVIEWED FOR THE BATCH NUMBER 9253437 AND THERE WAS NO REPORTED COMPLAINT OR QN RAISED ON THE SAME. THE INVESTIGATION TEAM ALSO CHECKED THE DHR LOG SHEET TO CHECK THE SPECIFICATIONS OF SILICONIZATION REGARDING THE SMOOTH MOVEMENT OF THE NEEDLE DURING INSERTION AND FOUND IT TO BE NORMAL. INVESTIGATION CONCLUSION: THE DEFECT IS NOT CONFIRMED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER NEEDLE WASN'T SUFFICIENTLY ATTACHED BEFORE USE, CAUSING IT TO "PULL BACK". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE ISN¿T SUFFICIENTLY ATTACHED SO THE NEEDLE IS PULLED BACK." DURING THE PENETRATION, THE NEEDLE MOVES MORE SMOOTHLY THEN USUAL WITHIN THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600344 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9253437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other