SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Catalog Number 100/850/060 |
Device Problem
Material Separation (1562)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: d4: udi section, lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that during removal of the inner cannula for cleaning the pull tabs broke off.Event took place in the patient's home.Event reported as resolved; product was replaced.
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Manufacturer Narrative
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Other text: additional information is provided in h.2., and h.6.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history record (dhr) review cannot be performed because a lot number was not provided.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.
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