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Model Number 01-EC-459-1401 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is in-progress.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 21cfr803, 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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Event Description
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Avanos medical, inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the first of four reports.Refer to 3011270181-2021-00002 for the second event.Refer to 3011270181-2021-00003 for the third event.Refer to 3011270181-2021-00004 for the fourth event.It was reported the closed suction catheter (csc) was "leaking secretions" near the thumb-port of the csc after suctioning of the patient.Additional information received 13-jan-2021 stated the csc was placed on the patient (b)(6) and the signs of leakage was discovered the (b)(6).There was no reported injury.
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Manufacturer Narrative
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The device history record for the reported lot number, 20062301, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-jun-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).This information is submitted pursuant to 21cfr803, 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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Search Alerts/Recalls
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