BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4110881 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32799
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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 PHOTOGRAPH OF THE DEVICE HAS BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, A PHOTO OF THE DEVICE WAS RECEIVED. VISUAL INSPECTION OF THE PHOTO DID NOT VERIFIED THE REPORTED CONDITION. A RETAINED SAMPLE WAS EVALUATED AND VISUAL INSPECTION AND FUNCTIONAL TESTING WERE COMPLETED. VISUAL INSPECTION AND FUNCTIONAL TESTING DID NOT REVEAL ANY ABNORMALITIES RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. IN ORDER TO ADDRESS THIS CONDITION THE INVOLVED PERSONNEL WERE GIVEN AWARENESS TRAINING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: (THE LOT WAS PRODUCED ON 02/23/2013 NOT 02/23/2014.) THE SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. DURING PHOTOGRAPHIC INSPECTION THE TUBING WAS OBSERVED TO BE SEPARATED FROM THE PORT 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 SEPARATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE Y-SITE SEPARATED FROM THE TUBING OF A SOLUTION ADMINISTRATION SET. THIS OCCURRED DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591649 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13B25V384

    Patients

    Seq Age Sex Outcome Treatment
    1