BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 8485095 · Received April 4, 2019

    Report

    Report Number
    8041187-2019-00280
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION AND THE INVESTIGATION COMPLETED THERE WAS NO OBSERVATION OF ADAPTER/CONNECTION ISSUES. PEELBACK WAS OBSERVED AND IS NOT REPORTABLE. 8041187-2019-00280 IS VOID AS THIS COMPLAINT IS NO LONGER REPORTABLE BASED ON THE REPORTING GUIDELINES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE PAST 12 MONTHS QN WAS PERFORMED. NO QN RELATED TO REPORTED DEFECT WAS RAISED. 4 PHOTOS WERE RETURNED FOR INVESTIGATION. FOR THE REPORTED ADAPTER/ CONNECTOR/ DEFECTIVE/ DAMAGED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF ADAPTER/ CONNECTOR/ DEFECTIVE/ DAMAGED FROM THE PHOTOS RETURNED. FOR CATHETER TIP INTEGRITY, BASED ON THE VERBATIM, IT IS SIMILAR TO CATHETER PEELBACK. FOR PEELBACK OF CATHETER, THE PROBABLE ROOT CAUSE COULD BE DUE TO TUBING MATERIAL. CAPA#81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEOFLON¿ IV CANNULA LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER IS EASILY BENT WITH POOR QUALITY. THE CATHETER LUER LOCK SOMETIMES GETS STUCK WITH RESISTANCE AND DIFFICULT TO REMOVE AFTER INSERTION. IT CAN CAUSE INJURY DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEOFLON¿ IV CANNULA LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER IS EASILY BENT WITH POOR QUALITY. THE CATHETER LUER LOCK SOMETIMES GETS STUCK WITH RESISTANCE AND DIFFICULT TO REMOVE AFTER INSERTION. IT CAN CAUSE INJURY DURING INSERTION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8201195. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE LOT #: 8201198. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEOFLON¿ IV CANNULA LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER IS EASILY BENT WITH POOR QUALITY. THE CATHETER LUER LOCK SOMETIMES GETS STUCK WITH RESISTANCE AND DIFFICULT TO REMOVE AFTER INSERTION. IT CAN CAUSE INJURY DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274926 BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other