BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY LL VLV ADPT(STAND ALONE)

    MDR report key: 10751544 · Received October 28, 2020

    Report

    Report Number
    2243072-2020-01749
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 19, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020 H.6. INVESTIGATION: TWO 2000E7D SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE SAMPLE WAS RECEIVED WITHOUT PACKAGING AND WITH RESIDUAL FLUID PRESENT, AS WELL AS RESIDUAL PATIENTS BLOOD IN THE MALE LUER. THE SECOND SAMPLE WAS RECEIVED IN SEALED PACKAGING. EXAMINATION OF THE SAMPLES CONFIRMED THE CUSTOMER'S EXPERIENCE AS LEAKAGE WAS OBSERVED FROM THE SAMPLE WITHOUT PACKAGING; UPON CLOSER INSPECTION IT WAS NOTED THAT THE SMARTSITE FEMALE LUER ADAPTOR (FLA) WAS OVAL, RATHER THAN CIRCULAR. EXAMINATION OF THE SAMPLE RECEIVED IN SEALED PACKAGING FOUND NO ISSUES; THE FLA WAS FOUND TO BE CIRCULAR AND NO LEAKAGE WAS OBSERVED. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1012189 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE OVAL SHAPE IS EXPOSURE OF THE SMARTSITE TO AN EXTERNAL HEAT SOURCE THAT BRINGS THE COMPONENT TEMPERATURE ABOVE 60°C. THE PISTON HEAD OF THE SMARTSITE IS OVAL SHAPED THEREFORE WHEN THE ROUND FLA COMPONENT IS PLACED OVER IT, THE PISTON OPENING IS SQUEEZED SHUT IN ORDER TO CREATE A SEAL. UNDER EXCESSIVE HEAT CONDITIONS, THE FLA MATERIAL CAN SOFTEN, AND AS THE PISTON PUSHES BACK ON THE INSIDE, IT CAN RESHAPE THE FLA TO CONFORM TO THE ORIGINAL OVAL SHAPE OF THE PISTON HEAD. PREVIOUS INVESTIGATIONS HAVE NOT FOUND A POTENTIAL ROOT CAUSE FOR THIS LEVEL OF EXCESS HEAT AS A RESULT OF ANY STAGE OF THE MANUFACTURING OR STERILIZATION PROCESSES AT THE MANUFACTURING SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7-DAY LL VLV ADPT(STAND ALONE) WAS CRACKED AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMART SITE NEEDLELESS CONNECTOR (IV BUNG) HAS POSSIBLE CRACK OR FAULTY ONE-WAY FLOW VALVE WHEN OPENED FROM PACKET. WAS INSERTING AN IV AND ATTACHED THE FLUSHED BUNG TO THE PATIENT AND IT STARTED DRIPPING BLOOD. I DOUBLE CHECKED THE CONNECTION AND THE INSERTION SITE AND REALIZED IT WAS COMING DIRECTLY FROM THE BLUE TIP OF THE BUNG. DISCONNECTED FROM THE PATIENT AND CHANGED IT. UPON INSPECTION OF THE ITEM THERE APPEARED TO BE A CRACK IN THE BLUE, FLAT END (NEEDLESS CONNECTOR SITE. I PUSHED WATER THROUGH THE OPPOSITE END AND SAW A STEADY STREAM OF WATER COMING OUT OF THE CRACK. REPORTED TO MANAGER AND GAVE HIM THE FAULTY ITEM TO KEEP FOR EVALUATION. ANOTHER COLLEAGUE REPORTED A SIMILAR EPISODE A FEW WEEKS AGO BUT IT WAS ON A BUSY SHIFT SO WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 1012189. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 7-DAY LL VLV ADPT (STAND ALONE) WAS CRACKED AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMART SITE NEEDLELESS CONNECTOR (IV BUNG) HAS POSSIBLE CRACK OR FAULTY ONE-WAY FLOW VALVE WHEN OPENED FROM PACKET. WAS INSERTING AN IV AND ATTACHED THE FLUSHED BUNG TO THE PATIENT AND IT STARTED DRIPPING BLOOD. I DOUBLE CHECKED THE CONNECTION AND THE INSERTION SITE AND REALIZED IT WAS COMING DIRECTLY FROM THE BLUE TIP OF THE BUNG. DISCONNECTED FROM THE PATIENT AND CHANGED IT. UPON INSPECTION OF THE ITEM THERE APPEARED TO BE A CRACK IN THE BLUE, FLAT END (NEEDLESS CONNECTOR SITE. I PUSHED WATER THROUGH THE OPPOSITE END AND SAW A STEADY STREAM OF WATER COMING OUT OF THE CRACK. REPORTED TO MANAGER AND GAVE HIM THE FAULTY ITEM TO KEEP FOR EVALUATION. ANOTHER COLLEAGUE REPORTED A SIMILAR EPISODE A FEW WEEKS AGO BUT IT WAS ON A BUSY SHIFT SO WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217658 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1