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(b)(4).An investigation was carried out into this complaint.Arjohuntleigh received a complaint where it was indicated that stitching inside of the yellow loop of the sling failed based on the information received.No injuries and no patient involvement was reported.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable.It has been established that the sling was not being used for patient handling at the time of the event.During our investigation the sling was found yellow loop stitching inside loop failed and was found to not have been to specification.The sling was not in use at the time for patient care and it did not cause or contribute to an adverse event, but it is the focus of our report and investigation.Tests carried out during the development of the sling, and in current production on every sling manufactured, would indicate the stitching of the loops meets the oem specification.A proper inspection of the sling should have detected the failure of this sling, especially since one of attachment points of the loop was broken.Therefore, the sling showing signs of unstitching, should be withdrawn and replaced.After reviewing the complaint it comes forward that the loop breakage appears most likely to occur as follows: as the pressure on the sling loop, in the opposite direction of that experienced in normal use which can be caused by the caregiver pulling the loops that way by hand, or, a much higher strain, where the loop/sling becoming caught in an obstruction.This appears to be an indication of the loop being broken due to the application of outside force that causes the break.Since the loop break is indicated to have occurred outside of use, it may have been caused even by becoming stuck during the mechanical washing or drying process.After this review, we can state the event outcome of the breaking off the loop, is not likely to happen when following the device labeling or the instructions for use (ifu).The sling is not likely to fail during the intended, correct use as described in the ifu, but that a failure can occur during a use error.We find it likely that the loop broke due to the loop suffering stress that is not likely to be encountered during on label use.We find this complaint to be reportable to the competent authorities in the abundance of caution.
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