Model Number MCK2-17-100-4 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device history record for the reported lot number, m7164d202, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 27-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
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Event Description
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It was reported the physician was inserting the introducer into patient's lumbar area.The physician removed the introducer, inspected it and set it aside.It was noted that the copper colored "wrapping" on the introducer had been pushed up exposing more of the silver material.The physician had difficulty pushing the needle through the tissue and there was an odd feeling when she tried to advance it and that is what made her remove the introducer for inspection.The physician was unable to use it for the rest of the bilateral lumbar radio frequency ablation (rfa).
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Manufacturer Narrative
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One fluid delivery introducer sample device was revived.No product packaging was received.The product did not contain a lot number.The device was evaluated and the failure was confirmed.The investigation was conduced and root cause was related to manufacturing.All information reasonably known as of 05-mar-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
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Search Alerts/Recalls
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