BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 10483402 · Received September 2, 2020

    Report

    Report Number
    8041187-2020-00529
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 12, 2020
    Report Date
    November 19, 2020
    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

    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: 2020-11-04. H6: INVESTIGATION SUMMARY TWO SYRINGES, ONE USED SAMPLE, AND TWO UNIT PACKAGES SHOWING BATCH 9325686 AND BATCH 0022876 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. AS THE SYRINGES DO NOT BELONG TO BD TUAS, NO FURTHER INVESTIGATION WAS DONE ON THEM. UPON VISUAL INSPECTION OF THE SAMPLE IT WAS OBSERVED THAT THE VALVE HAD MOVED TOWARDS THE CANNULA HUB LUER SIDE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCHES FROM THE TWO UNIT PACKAGES. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE INJECTION VALVE MOVING WITHIN THE CANNULA HUB. CAPA#1379444 HAS BEEN INITIATED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9325686. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2019-11-21. D.4. MEDICAL DEVICE LOT #: 0022876. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. H.4. DEVICE MANUFACTURE DATE: 2020-01-22.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD FROM THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINS THAT BLOOD IS RUNNING OUT OF THE INJECTION PORT OF THE VENOUS CATHETER. THE INCIDENT HAVE OCCURRED SEVERAL TIMES IN THE PAST. ONLY THE SIZE MENTIONED IS AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD FROM THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINS THAT BLOOD IS RUNNING OUT OF THE INJECTION PORT OF THE VENOUS CATHETER. THE INCIDENT HAVE OCCURRED SEVERAL TIMES IN THE PAST. ONLY THE SIZE MENTIONED IS AFFECTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD FROM THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINS THAT BLOOD IS RUNNING OUT OF THE INJECTION PORT OF THE VENOUS CATHETER. THE INCIDENT HAVE OCCURRED SEVERAL TIMES IN THE PAST. ONLY THE SIZE MENTIONED IS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950086 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other