The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebn0554 showed one other similar product complaint from this lot number.
|
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a defective guidewire is confirmed, but the cause remains unknown.The sample returned consisted of two photographs, each of a powerglide pro device reportedly a pflex, 18g 10 cm full w/ guardiva set.Visual observation found the first photograph to show the powerglide pro with the guidewire not extending out of the needle, although the guidewire slider was moved forward, the catheter not deployed, and the catheter wings in a proximal position.The second photograph shows a powerglide device from the side, with the wings in the proximal position and the catheter not deployed.The guidewire carriage component within the device was not visible, suggesting it was advanced forward; however, the wire was found far towards the back of the device, indicating it was not properly seated in the carriage.It is not known how the guidewire became improperly situated, but the report states that when insertion was attempted and could not be completed, the device was examined and it was found that the guidewire was, at that time, partially deployed out of the needle.Therefore, it is reasonable to believe that the wire was caught between the needle and the skin, preventing insertion.If, during insertion, pressure continued to be applied to the guidewire slider, the guidewire may have bowed such that it was pushed out of the guidewire carriage.This would explain why, when retrograde guidewire motion was then attempted, the guidewire retreated fully into the device.Alternatively, the guidewire may have been out of place when the procedure began.The sequence of events is not known, and therefore the cause is unknown.
|