The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2023 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).This information is submitted pursuant to (b)(4), in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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It was reported "the black tip to 1 of the catheter(s) was retained in the patient.Clients husband called to report no black tip on one of catheters when removing dual onq pump from wife.He pulled a little and then she got frustrated and began to tug on it and it came out without black tip.Doctor stated that the catheter should be fine to remain inside the patient.No redness, swelling, discharge, fever, increase in pain, or other signs of infection noted at or around catheter insertion site.".
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