BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ADAPTOR SET

    MDR report key: 1904819 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05037
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. THIS SET WAS VISUALLY INSPECTED AND CONFIRMED THAT THE VENTED CAP OF THE SYRINGE WAS CRACKED. THE COMPLAINTS RECEIVED FOR THIS PRODUCT WERE UNDER REVIEW TO CONFIRM THAT NO OTHER SIMILAR INCIDENT WAS REPORTED; HENCE, NO NEGATIVE TREND COULD BE ASSOCIATED TO THIS COMPLAINT AND IT COULD BE CLASSIFIED AS A SINGLE OCCURRENCE DEFECT. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A SYRINGE ADAPTOR SET THAT HAS A BROKEN FILTER AND CAUSING THE MEDICATION TO LEAK. THE CONDITION OCCURRED ON (B)(6) 2010. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYRINGE ADAPTOR SET SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 10E25V356M

    Patients

    Seq Age Sex Outcome Treatment
    1