BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1710034-2017-00101

    MDR report key: 6702347 · Received July 11, 2017

    Report

    Report Number
    1710034-2017-00101
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 20, 2017
    Report Date
    August 29, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR INVESTIGATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THE UNIT CONSISTED OF THE WINGED ADAPTER/FRONT BARREL, REAR BARREL/HUB/EXTENSION TUBE, SPRING AND BROKEN LEVEL ARM. THERE WAS NO DAMAGE TO THE FRONT OR REAR BARRELS BUT THE LEVEL ARM WAS BROKEN OFF FROM THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7062501. CONCLUSION: ALTHOUGH THE CUSTOMER'S REPORTED DEFECT WAS CONFIRMED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN RETRACTING THE NEEDLE OF A BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING 21 G X .75 IN, THE NEEDLE AND SPRING SEPARATED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other