BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA

    MDR report key: 17140099 · Received June 15, 2023

    Report

    Report Number
    8041187-2023-00278
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 10, 2023
    Report Date
    July 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 21-JUNE-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 3 REPRESENTATIVE SAMPLES, 1 FOR BATCH 1357424 AND 2 FOR BATCH 2111014, SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CONNECTOR LOOSE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. THE RETURNED PHOTO SHOWED A NON-BD PRODUCT, SO IT COULD NOT BE USED TO EVALUATE THE INCIDENT REPORTED. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO ABNORMALITIES OR DEFECTS OBSERVED. THE LUER CONES OF ALL THE RETURNED SAMPLES WERE MEASURED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1357424 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H.4. DEVICE MANUFACTURE DATE: 19-JAN-2022 D.4. MEDICAL DEVICE LOT #: 2111014 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025 H.4. DEVICE MANUFACTURE DATE: 23-MAY-2022 H.3. 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 · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA THE CONNECTOR WAS UNABLE TO ATTACH TO COMPONENT, THUS RESULTING IN LEAKAGE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE HEREBY INFORM YOU THAT WE HAVE RECEIVED A REPORT FROM HOSPITAL REGARDING THE VENFLON PRO SAFETY, COD. 393224 LOT 1357424 AND 2111014, THEY REPORT THAT THEY HAVE ENCOUNTERED PROBLEMS WITH ADHESION BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA THE CONNECTOR WAS UNABLE TO ATTACH TO COMPONENT, THUS RESULTING IN LEAKAGE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE HEREBY INFORM YOU THAT WE HAVE RECEIVED A REPORT FROM HOSPITAL REGARDING THE VENFLON PRO SAFETY, COD. 393224 LOT 1357424 AND 2111014, THEY REPORT THAT THEY HAVE ENCOUNTERED PROBLEMS WITH ADHESION BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839367 BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown