BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3092399 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11253
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.EVALUATION SUMMARY:THE ACTUAL SAMPLE AND ONE COMPANION SAMPLE, FROM THE SAME LOT, WERE EVALUATED. VISUAL EXAMINATION OF THE ACTUAL SAMPLE NOTED THAT A SECTION OF THE MALE LUER SHAFT WAS MISSING AND WHITE STRESS MARKS WERE FOUND AROUND THE OPENING. THIS WAS LOCATED ON THE OPPOSITE SIDE OF THE MISSING SECTION. VISUAL EXAMINATION OF THE COMPANION SAMPLE NOTED NO SIGN OF PHYSICAL ABNORMALITY. HOWEVER, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK SYSTEM SECONDARY MEDICATION SET LEAKED. DURING INFUSION, THE NURSE OBSERVED AN UNKNOWN MEDICATION LEAKING FROM THE LUER ATTACHED TO THE PRIMARY LINE. THE LUER WAS NOTED TO HAVE A ?1.5 CM LONG BY 1/3 DIAMETER? CHUNK MISSING; WITH A SOLID WHITE ACCENT. THE AMOUNT OF MEDICATION SPILLED IS UNKNOWN. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195350 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12125012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PRIMARY SET| UNKNOWN MEDICATION