BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR (C180J)

    MDR report key: 16856494 · Received May 2, 2023

    Report

    Report Number
    3003152976-2023-00155
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 11, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2210215 D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025 H4: DEVICE MANUFACTURE DATE: 25-JAN-2023 D4: MEDICAL DEVICE LOT #: 2210216 D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025 H4: DEVICE MANUFACTURE DATE: 25-JAN-2023 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SPIKE IS OBSERVED TO BE DISCONNECTED FROM THE CONNECTOR. IT WAS NOTED THERE IS VISIBLE TRACES OF THE SOLVENT USED TO ADHERE THE SPIKE TO THE CONNECTOR, INDICATING IT WAS APPLIED, HOWEVER, WE CANNOT VERIFY IT WAS THE PROPER QUANTITY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2210215, 2210216 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED. UPON PERFORMING ASSEMBLY FORCE TESTING, ALL PRODUCT MET REQUIRED SPECIFICATIONS. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. ALTHOUGH WE COULD NOT IDENTIFY A DIRECT PROBLEM, IT WAS DETERMINED THIS INCIDENT WAS LIKELY RELATED TO A FAILURE IN THE DISPENSER THAT DOSES THE SOLVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) SEPARATED FROM THE SALINE BOTTLE DURING USE AND LEAKED AT THE SPIKE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT DISCONNECTION OF SPIKE AND C35 OF C180J. THE CUSTOMER'S REPORT IS AS FOLLOWS: A SALINE BOTTLE AND AN IV LINE WERE CONNECTED WITHOUT ANY PROBLEM, UPON PRIMING WITH SALINE. AFTER THAT, THE IV LINE SUDDENLY FELL OFF THE BOTTLE, AND THE CONNECTION OF THE SPIKE AND C35 OF 180J WAS DETACHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) SEPARATED FROM THE SALINE BOTTLE DURING USE AND LEAKED AT THE SPIKE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT DISCONNECTION OF SPIKE AND C35 OF C180J. THE CUSTOMER'S REPORT IS AS FOLLOWS: A SALINE BOTTLE AND AN IV LINE WERE CONNECTED WITHOUT ANY PROBLEM, UPON PRIMING WITH SALINE. AFTER THAT, THE IV LINE SUDDENLY FELL OFF THE BOTTLE, AND THE CONNECTION OF THE SPIKE AND C35 OF 180J WAS DETACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711386 BD PHASEAL¿ SPIKE CONNECTOR (C180J) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown