BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3760140 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12722
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION ON THE AFFECTED DEVICE COULD NOT BE CONDUCTED. HOWEVER, AN EVALUATION WAS PERFORMED ON A RESERVED SAMPLE (VISUAL INSPECTION AND GRAVITY USE-TESTING). THE DEVICE OPERATED WITHIN THE DESIRED PRODUCT SPECIFICATIONS AND NO ISSUES WERE NOTED DURING THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WILL BE PERFORMED.  IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHT SENSITIVE DRUG SET HAD A TINY HOLE. THE REPORTER STATED THAT THE HOLE WAS OBSERVED TO LET AIR ENTER THE PRODUCT. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236987 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13K13V374

    Patients

    Seq Age Sex Outcome Treatment
    1