BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 BL 22GA IV CANNULA

    MDR report key: 12185429 · Received July 16, 2021

    Report

    Report Number
    2243072-2021-01892
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 19, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4) . THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF A VENFLON FROM LOT # 0182212 REGARDING ITEM # 391451 WITH THE REPORTED ISSUE THAT ¿THE NEEDLE WAS PLACED WITH THE INJECTION PORT OPEN, SO THE LEAKAGE WAS DISCOVERED IMMEDIATELY¿. THE DHR OF LOT NUMBER 391451 AND BATCH NUMBER OF 0.0182212 WAS REVIEWED AND NO QUALITY NOTIFICATION WAS FOUND ON THIS LOT NUMBER. NO SAMPLES AND THREE PHOTOGRAPHS RECEIVED FROM THE CUSTOMER. THE INVESTIGATING TEAM HAS USED THE PHOTOGRAPHS AND RETENTION SAMPLES OF MATERIAL CODE 391451 AND LOT NUMBER 0182212 FOR INVESTIGATING THE REPORTED DEFECT. THIS IS AN ISSUE OF LEAKAGE, ROOT CAUSE IS THAT THE LEAKAGE HAPPENS DUE TO THE SILICON VALVE SHIFTING FROM ITS POSITION DURING MEDICATION FROM ITS INJECTION PORT. SILICONE VALVE LEAKAGE IS CHECKED FOR 100% OF THE COMPONENTS. IN ADDITION TO THIS A ¿IN PROCESS QUALITY CHECKS¿ THAT ARE DONE BY LINE OPERATOR AND ALSO BY QUALITY ASSOCIATES. THESE CHECKS ENSURE THAT SUCH DEFECTIVE PRODUCTS DON¿T PASS THROUGH FROM THE LINE. THE MANUFACTURING TEAM ALSO DID CROSS VERIFICATION ON THE LINE AND NO ISSUE OBSERVED WHICH CAN PASS SUCH DEFECTS FROM THE LINE. SINCE NO RETENTION SAMPLES HAVE CONFIRMED THE DEFECT AND NO SAMPLE RECEIVED, THE DEFECT CANNOT BE CONFIRMED. ATTACHED ALONG WITH THE REPORT ARE THE LOGS OF THE IPQC AND THE QUALITY TESTS DONE FROM THE DHR OF 0182212. BASED ON THE PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON 2 BL 22GA IV CANNULA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS PLACED WITH THE INJECTION PORT OPEN SO THE LEAKAGE WAS DISCOVERED IMMEDIATELY. A LOT OF BLOOD CAME THRU THE INJECTION PORT AND THE NEEDLE WAS REMOVED INSTANTLY. NO INJURY FOR PATIENT (DOG) OTHER THAN UNCOMFORTED. THE CATHETER IS SAVED IF WE WANT TO TAKE IT IN FOR OVERVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON 2 BL 22GA IV CANNULA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS PLACED WITH THE INJECTION PORT OPEN SO THE LEAKAGE WAS DISCOVERED IMMEDIATELY. A LOT OF BLOOD CAME THRU THE INJECTION PORT AND THE NEEDLE WAS REMOVED INSTANTLY. NO INJURY FOR PATIENT(DOG) OTHER THAN UNCOMFORTED. THE CATHETER IS SAVED IF WE WANT TO TAKE IT IN FOR OVERVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077955 VENFLON 2 BL 22GA IV CANNULA CATHETER FOZ 0182212

    Patients

    Seq Age Sex Outcome Treatment
    1