BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4883381 · Received July 1, 2015

    Report

    Report Number
    1416980-2015-27391
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 5, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED; HOWEVER, A COMPANION SAMPLE WAS PROVIDED FOR EVALUATION. DURING VISUAL INSPECTION OF THE COMPANION SAMPLE, A LACK OF SOLVENT WAS OBSERVED AT THE JUNCTION OF THE SPIKE AND TUBING. DURING PULL TESTING THE SPIKE BECAME SEPARATED FROM THE TUBING OF THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE CONDITION IS DUE TO SIZE OF THE TUBING AND A LACK OF SOLVENT AT THE JUNCTION. TO CORRECT THE CONDITION, THE TUBING DIAMETER WAS MADE SMALLER AND DEVICE OPERATORS WERE RE-CERTIFIED FOR ASSEMBLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A UROMATIC ADMINISTRATION SET DETACHED FROM THE SPIKE. THIS OCCURRED WHEN THE SOLUTION BAG HAD PRESSURE APPLIED TO IT. A PATIENT WAS CONNECTED TO THE SETUP WHEN THIS OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428908 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - MALTA 14K03V521

    Patients

    Seq Age Sex Outcome Treatment
    1