BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 15020501 · Received July 14, 2022

    Report

    Report Number
    8041187-2022-00376
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2083721. MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. DEVICE MANUFACTURE DATE: 2022-04-12. MEDICAL DEVICE LOT #: 1274196. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2021-10-26. MEDICAL DEVICE LOT #: 1357412. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2022-01-13. 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: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 29-JUL-2022. INVESTIGATION SUMMARY FIVE REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THREE SAMPLES WERE RECEIVED FROM BATCH 2083721, ONE SAMPLE WAS RECEIVED FROM BATCH 1357412, AND ONE SAMPLE WAS RECEIVED FROM BATCH 1274196. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND LUER CONE MEASUREMENT. ALL INSPECTIONS PASSED, AND NO ABNORMALITIES WERE OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROBABLE ROOT CAUSE FOR THE SARSTEDT ADAPTER TO SLIP OUT COULD BE DUE TO THE USER NOT FITTING THE ADAPTER WITH THE CANNULA HUB PROPERLY AND CAUSE THE CONNECTION TO BE LOOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS WERE UNABLE TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SARSTEDT ADAPTER DOES NOT REMAIN IN THE HUB OF THE CATHETER AS USUAL, "JUMPS OUT" AGAIN AND AGAIN, BLOOD RUNS ALONGSIDE BETWEEN ADAPTER AND HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS WERE UNABLE TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SARSTEDT ADAPTER DOES NOT REMAIN IN THE HUB OF THE CATHETER AS USUAL, "JUMPS OUT" AGAIN AND AGAIN, BLOOD RUNS ALONGSIDE BETWEEN ADAPTER AND HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062491 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown