On (b)(6) 2023, (b)(6) of (b)(6) hospital notified the avi complaints department that he had a midline that was infiltrated and had to be removed.Upon removal, it was noted to have a hole in the catheter wall, about 3-4 centimeters from the catheter hub.He provided a photo (see attachment 1), but the line was not saved for return to avi.In a follow-up e-mail on 18 jan 2024, (b)(6) stated that his team had difficulty with flushing and blood return post-insertion and that it "appeared positional." the line was then "retracted" at one point, but the patient's arm appeared swollen, so the line was removed.The photo provided shows a visible defect in the catheter wall, however, it's not possible to further investigate the cause without return of the device.Lee confirmed that it was inserted per the ifu.Their protocol is to flush every 12 hours, however, he was unable to confirm that the flushing occurred as saline flushes are not documented on the emar (electronic medication administration record).The lot number provided by lee, #10262301, was determined to be incorrect.This corresponds with a catheter lot number that has not yet shipped from avi.Hartford hospital has received several lots of fg 80004104 kits, so the actual lot number cannot be determined.An lhr review is not applicable.With the limited information provided and without return of the device, avi is unable to determine a root cause.
|