BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3942434 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23083
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE OF THE PATIENT IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE A (B)(6). IT WAS REPORTED THAT A PARENTAL NUTRITION BAG WAS USED AT THE TIME OF THE EVENT AND THE DEVICE WAS USED WITH AN SINGLE-CHANNEL INFUSION PUMP.) EVALUATION SUMMARY: THE CUSTOMER DID NOT RETURN THE ACTUAL SAMPLE; HOWEVER, THEY DID PROVIDE A PHOTOGRAPH. A PHOTOGRAPHIC INSPECTION IDENTIFIED THAT THERE WAS A HOLE IN THE TUBING. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHT SENSITIVE DRUG SET LEAKED. THIS MALFUNCTION OCCURRED DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT.. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419655 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 14A06V068

    Patients

    Seq Age Sex Outcome Treatment
    1 PARENTAL NUTRITION BAG, SINGLE-CHANNEL PUMP