BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ INFUSION SET WITH FILTER

    MDR report key: 6773004 · Received August 8, 2017

    Report

    Report Number
    9610847-2017-00050
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 7, 2017
    Report Date
    October 27, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO OF THE AFFECTED PRODUCT SHOWED THE REPORTED DEFECT. RETENTION SAMPLES WERE ALSO EVALUATED AND SIMILAR DEFECTS WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7110528. A MANUFACTURING REVIEW INDICATED THAT PREVENTATIVE MAINTENANCE, CALIBRATION, AND EQUIPMENT IS NOT DIRECTLY INVOLVED WITH THE PACKAGING INSPECTION AND WOULD NOT HAVE INFLUENCED THE REPORTED DEFECT. CONCLUSION: THE EVALUATION OF THE RETURNED PHOTO AND RETENTION SAMPLES CONFIRMED THE REPORTED DEFECT AND IT HAS BEEN DETERMINED THAT T\IT IS RELATED TO THE PACKAGING PROCESS. A CAPA HAS BEEN IMPLEMENTED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FOREIGN MATTER IN THE FLUID PATHWAY BEFORE USE WITH A BD SAFETY-LOK¿ INFUSION SET . NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553218 BD SAFETY-LOK¿ INFUSION SET WITH FILTER INTERVASCULAR CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7110528

    Patients

    Seq Age Sex Outcome Treatment
    1 Other