BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9667288 · Received February 4, 2020

    Report

    Report Number
    8041187-2020-00041
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    December 9, 2019
    Report Date
    March 19, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS AND EIGHT REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE RETURNED PHOTOS SHOW THE TOP WEB WITH BATCH NUMBER. THE EIGHT REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, VALVE INJECTION TEST, AND CATHETER ADAPTER LEAK TEST. THE EIGHT REPRESENTATIVE SAMPLES PASSED THE VISUAL INSPECTION AND ACCEPTANCE CRITERIA ON VALVE INJECTION TEST AND CATHETER ADAPTER LEAK TEST. NO ABNORMALITY WAS OBSERVED; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. SINCE ALL OF THE SAMPLES PASSED TESTING A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INDUCTION OF ANESTHESIA A "POPPING" SOUND OCCURRED AND BLOOD LEAKED THROUGH THE PORT WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INDUCTION OF ANESTHESIA VIA THE DRUG PORT OF A FRESHLY INSERTED 14G BD VENFLON PRO SAFETY, A 'POPPING' SENSATION WAS FELT FOLLOWED BY THE IMMEDIATE FREE FLOW OF BLOOD BACK THROUGH THE DRUG PORT ON THE REMOVAL OF THE SYRINGE. THE BLOOD FLOW DID NOT STOP WITH CLOSURE OF THE ORANGE CAP AND ONLY STOPPED WITH MANUAL OCCLUSION OF THE DRUG PORT WITH GAUZE AND PRESSURE. THE PATIENT LOST A SMALL VOLUME OF BLOOD (<50MLS) AND SOME OF THE INDUCTION DRUGS MAY HAVE BEEN LOST ALONG WITH THE BLOOD. THE CANNULA HAD TO BE REMOVED SO THE PATIENT HAD A SECOND CANNULATION THAT WOULD HAVE BEEN UNNECESSARY OTHERWISE.

    Additional Manufacturer Narrative · 1

    "THERE WERE MULTIPLE "POSSIBLE" LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9060946. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2019-03-15. MEDICAL DEVICE LOT #: 9241669. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2019-08-29. MEDICAL DEVICE LOT #: 9270361. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2019-09-27. " INITIAL REPORTER PHONE #: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT DURING INDUCTION OF ANESTHESIA A "POPPING" SOUND OCCURRED AND BLOOD LEAKED THROUGH THE PORT WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INDUCTION OF ANESTHESIA VIA THE DRUG PORT OF A FRESHLY INSERTED 14G BD VENFLON PRO SAFETY, A 'POPPING' SENSATION WAS FELT FOLLOWED BY THE IMMEDIATE FREE FLOW OF BLOOD BACK THROUGH THE DRUG PORT ON THE REMOVAL OF THE SYRINGE. THE BLOOD FLOW DID NOT STOP WITH CLOSURE OF THE ORANGE CAP AND ONLY STOPPED WITH MANUAL OCCLUSION OF THE DRUG PORT WITH GAUZE AND PRESSURE. THE PATIENT LOST A SMALL VOLUME OF BLOOD (<50MLS) AND SOME OF THE INDUCTION DRUGS MAY HAVE BEEN LOST ALONG WITH THE BLOOD. THE CANNULA HAD TO BE REMOVED SO THE PATIENT HAD A SECOND CANNULATION THAT WOULD HAVE BEEN UNNECESSARY OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132273 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CTHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other