A review of the device history record is not possible as no lot number was provided.The actual complaint product was returned for evaluation.The root cause of the reported issue could not be conclusively determined.However; this seems to be a user related problem since as per the ifu, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 24 sep 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).
|
It was reported that the ng [nasogastric] tube was "broken." according to the report, the "patient [was] fussy all day with feeds, kub [kidney-ureter-bladder x-ray] obtained which showed that ngt was broken in patient's stomach (distal tip hanging on by a thread).Ngt pulled and replaced." no injury was reported.
|