BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9805641 · Received March 9, 2020

    Report

    Report Number
    8041187-2020-00128
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 6 PHOTOS WERE RETURNED FOR INVESTIGATION. THE RETURNED PHOTOS SHOW LEAKAGE FROM INJECTION PORT AND VALVE MOVED WAS OBSERVED. DHR REVIEWED WAS PERFORMED ON BATCH #9241570. THIS BATCH WAS BUILT WITH VA48 IN SEP 19. MACHINE HISTORY RECORD WAS REVIEWED. NO ABNORMALITY WAS OBSERVED. CANNULA HUB BATCH #9208774 AND #9235614 (MATERIAL NO: 8607877) WERE REVIEWED. NO QN WAS RAISED. TUBE SILICONE BATCH #11087471 (MATERIAL NO: 8612315) WAS REVIEWED. NO QN WAS RAISED. NO QN WAS RAISED ON BATCH #9241570 (CATALOG NO: 393226). NO SIMILAR QN WAS RAISED FOR THE PAST 12 MONTHS ON THE REPORTED DEFECT. INVESTIGATION CONCLUSION: ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE RETURNED PHOTOS. ROOT CAUSE DESCRIPTION: THE LEAKAGE WAS DUE TO INJECTION VALVE MOVE WITHIN THE CANNULA HUB. RATIONALE: CAPA#(B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD FLOWED OUT OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER DURING USE AFTER CLOSING THE INJECTION PORT. THE CATHETER WAS USED TO DELIVER "PREOPERATIVE" MEDICATION TO THE PATIENT. CAPA# (B)(4) WAS OPENED IN RESPONSE TO THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE FOLLOWING PHENOMENON HAS ALREADY BEEN OBSERVED SEVERAL TIMES IN THE LAST WEEK: THE VENOUS CATHETER IS PLACED ON THE WARD. THE PATIENT RECEIVES PREOPERATIVE MEDICATION THROUGH THIS VENOUS CATHETER. IN THE OPERATING ROOM FURTHER MEDICATION IS ADMINISTERED VIA THE INJECTION PORT, AFTER WHICH THE INJECTION PORT IS CLOSED AGAIN WITH THE CAP. (THESE MEDICATIONS ARE ALSO DRAWN UP IN SYRINGES FROM GLASS AMPOULES BOTH WITHOUT A CANNULA AND WITH A CANNULA WITHOUT A FILTER). THE VENOUS CATHETER IS PROVIDED WITH A BACK CHECK VALVE. NOW, AFTER CLOSING THE INJECTION PORT OF SOME CATHETERS, IT HAS BEEN OBSERVED THAT BLOOD FLOWED OUT OF IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267824 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9241570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other