BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER

    MDR report key: 14436510 · Received May 19, 2022

    Report

    Report Number
    2243072-2022-00702
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 16, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868636
    PMA / PMN Number
    K201717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: DEVICE NAME UPDATED. D4 .MEDICAL DEVICE MATERIAL #:386863. D4. MEDICAL DEVICE LOT #:1324334. D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 30NOV 2024. D4. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL (SINGAPORE). G1. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL (SINGAPORE). G5. PMA / 510(K)# : K201717. H4. DEVICE MANUFACTURE DATE: 20 NOV 2021. H6. INVESTIGATION SUMMARY: BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. FROM THE RETURNED PHOTO, THE SAFETY MECHANISM WAS NOT FULLY ACTIVATED AND THERE WAS BLOOD AT THE NEEDLE HUB FLASHBACK CHAMBER. HOWEVER, UNABLE TO EVALUATE FROM THE PHOTO WHETHER THERE IS DENT ON THE CANNULA OR SAFETY ACTIVATION COMPONENTS FAILURE/DAMAGE THAT RESULTED IN THE SAFETY ACTIVATION FAILURE. AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION, ACTUAL ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 UNSPECIFIED BD CATHENA¿ IV CATHETERS' SAFETY SHIELD MECHANISMS FAILED TO ACTIVATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 2 CATHENA IV CATHETERS IN MY OFFICE FROM ER THAT THE SAFETY FEATURE DIDN¿T DEPLOY. WHEN THEY PULLED THE NEEDLE OUT, THE HUB DIDN¿T SLIDE INTO PLACE OVER THE END OF THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD CATHENA¿ SAFETY IV CATHETERS' SAFETY SHIELD MECHANISMS FAILED TO ACTIVATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 2 CATHENA IV CATHETERS IN MY OFFICE FROM ER THAT THE SAFETY FEATURE DIDN¿T DEPLOY. WHEN THEY PULLED THE NEEDLE OUT, THE HUB DIDN¿T SLIDE INTO PLACE OVER THE END OF THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344267 BD CATHENA¿ SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386863 1324334 00382903868636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown