BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L

    MDR report key: 11600580 · Received March 31, 2021

    Report

    Report Number
    8041187-2021-00236
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 7, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE VIDEO SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE VIDEO, LEAKAGE FROM THE INJECTION PORT DUE TO A MOVED VALVE WAS OBSERVED WHEN FLUSHING FROM THE CANNULA HUB. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO A VALVE ISSUE. CAPA 1379444 HAS BEEN INITIATED. DHR REVIEWED WAS PERFORMED ON BATCH# 0036001 ¿ THIS BATCH WAS BUILT WITH VA41 IN (B)(6)2020. ¿ MACHINE HISTORY RECORD WAS REVIEWED. NO ABNORMALITY WAS OBSERVED. ¿ CANNULA HUB BATCH # 0021321 AND #0008224 (MATERIAL NO: 8607877) WERE REVIEWED. NO QN WAS RAISED. ¿ TUBE SILICONE BATCH # 11092702 (MATERIAL NO: 8612315) WAS REVIEWED. NO QN WAS RAISED. ¿ NO SIMILAR QN WAS RAISED ON BATCH# 0036001 (CATALOG NO: 393227). ¿ NO SIMILAR QN WAS RAISED FOR THE PAST 12 MONTHS ON THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM THE INJECTION PORT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM THE INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495889 VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0036001

    Patients

    Seq Age Sex Outcome Treatment
    1