BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTO ADMIN 4 LINE SET C110

    MDR report key: 10752537 · Received October 28, 2020

    Report

    Report Number
    2243072-2020-01760
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 6, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-19. H6: INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINED ABOUT A CYTO-AD Z®INLINE/4 (BD PRODUCT CODE C110) BECAUSE THE USER NOTICED A LEAKAGE FROM THE SPIKE DURING PRIMING. INITIALLY A PHOTO OF THE DEFECTIVE SET AND LATER THE ORIGINAL SAMPLE WERE PROVIDED UNEXPECTEDLY. THE PHOTO SHOWED A CYTO-AD Z®INLINE/4 BEING WRAPPED IN A TRANSPARENT PLASTIC BAG. THE DEVICE WAS COMPLETE. A PROTECTIVE CAP WAS ON THE SPIKE AND SEALING PLUGS ON THE FOUR SIDE PORTS. THE GREEN CODAN CAP STOOD OPEN. THE SPIKE APPEARED TO BE FIRMLY FIXED TO THE TUBING. NEITHER THE SPIKE NOR THE REMAINING DEVICE SHOWED ANY DAMAGES. SOME FLUID DROPS WERE VISIBLE IN THE BAG IN THE RANGE OF THE SPIKE. APPARENTLY THIS WAS TO FURNISH EVIDENCE OF THE LEAKAGE. HOWEVER, THE SOURCE OF THE LEAK WAS NOT DETERMINABLE. THE SAMPLE AT HAND WAS THE PHOTOGRAPHED SET. THE TUBING WAS FILLED WITH CLEAR SOLUTION FROM THE PRIMING PROCESS. THE SAMPLE WAS LEAK TESTED UNDER GRAVITY BY CONNECTING IT TO A FLEXIBLE INFUSION BAG. THE CODAN CAP WAS LEFT OPEN AND THE CLAMP LEFT CLOSED. AT THIS NO LEAKAGE IN THE AREA OF THE SPIKE WAS IDENTIFIED, EVEN WHEN THE INFUSION BAG WAS PRESSED. AFTER OPENING OF THE INLINE CLAMP, THE INLINE-SPIKE-ADAPTER OF THE SET STARTED TO LEAK SIGNIFICANTLY FROM A FLAW IN THE COMPONENT WALL UPSIDE THE FRONT HANDLES. MAIN CAUSE: APPARENTLY THE USER OF THE SET DID NOT DESCRIBE THE SOURCE OF THE LEAKAGE CORRECTLY. UPON VISUAL INSPECTION WITH HELP OF A MAGNIFIER, THE FLAW REVEALED TO BE MADE OF SWIRLED JETS OF MELTED GRANULATE. EVIDENTLY IT WAS A MOULDING ANOMALY. IN NO CASE THE FLAW WAS THE RESULT OF EXTERNAL DAMAGING. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER L70891-1. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CYTO ADMIN 4 LINE SET C110 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRIMING OF THE C110 WITH SALINE, THE NURSE NOTICED THAT THE C110 IS LEAKING FROM THE SPIKE CONNECTION.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS OEM. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CYTO ADMIN 4 LINE SET C110 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRIMING OF THE C110 WITH SALINE, THE NURSE NOTICED THAT THE C110 IS LEAKING FROM THE SPIKE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217810 CYTO ADMIN 4 LINE SET C110 ADMIN LINE SET FPA BECTON DICKINSON L70891-1

    Patients

    Seq Age Sex Outcome Treatment
    1