BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L

    MDR report key: 11307263 · Received February 10, 2021

    Report

    Report Number
    8041187-2021-00079
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 25, 2021
    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 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0153325. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. H.4. DEVICE MANUFACTURE DATE: 2020-06-01. H.6. INVESTIGATION SUMMARY: ONE REPRESENTATIVE SAMPLE AND ONE USED SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE USED SAMPLE, THE VALVE WAS OBSERVED TO HAVE MOVED. THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION, INJECTION LEAK TEST, AND THE CATHETER ADAPTER LEAK TEST. THE SAMPLE PASSED ALL TESTING AND NO ABNORMALITIES WERE OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. INVESTIGATION CONCLUSION: THIS EVENT HAS BEEN ADDED TO OUR COMPLAINT DATABASE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE MOVING VALVE. RATIONALE: BASED ON THE INVESTIGATION, THE LEAKAGE WAS DUE TO VALVE MOVED ISSUE. CAPA# 1379444 HAS BEEN INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L WAS BROKEN AND LEAKED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR A SPINAL DECOMPRESSION A 16 G BD VENFLON PRO SAFETY WAS PLACED. DURING THE RELOCATION ON THE STOMACH IT WAS NOTICED THAT THE SURROUNDINGS OF THE DEVICE WERE BLOODY, THE BANDAGE WAS BLOODY AS WELL AND A TRICKLE WAS COMING OUT OF THE DEVICE. DURING A FURTHER INSPECTION WE NOTICED THAT THE CHECK-VALVE IN THE INJECTION PORT BELOW THE GREY CAP WAS NOT WORKING PROPERLY. ALTERNATELY, BLOOD AND STEROFUNDIN LEAKED THRROUGH THE UPPER PART. THE PROBLEM STOPPED AFTER PLACING A BRAUN VASOFIX CANNULA.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE#: (B)(6). 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 VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L WAS BROKEN AND LEAKED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR A SPINAL DECOMPRESSION A 16 G BD VENFLON PRO SAFETY WAS PLACED. DURING THE RELOCATION ON THE STOMACH IT WAS NOTICED THAT THE SURROUNDINGS OF THE DEVICE WERE BLOODY, THE BANDAGE WAS BLOODY AS WELL AND A TRICKLE WAS COMING OUT OF THE DEVICE. DURING A FURTHER INSPECTION WE NOTICED THAT THE CHECK-VALVE IN THE INJECTION PORT BELOW THE GREY CAP WAS NOT WORKING PROPERLY. ALTERNATELY, BLOOD AND STEROFUNDIN LEAKED THROUGH THE UPPER PART. THE PROBLEM STOPPED AFTER PLACING A BRAUN VASOFIX CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205540 VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0153325

    Patients

    Seq Age Sex Outcome Treatment
    1