SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEOSTOMY CARE KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that there is a clinician misuse issue, stating the procedure for the ciaglia technique is "almost never followed".The clinician began to make a horizontal or vertical incision instead of starting to identify and mark the anatomical landmarks.It was reported that the clinician reversed steps 3 and 4 in the ifu.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Catalog number, lot number, expiration date, and udi section and device 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 required.
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Manufacturer Narrative
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Other text: h6: event methods, evaluation, and conclusion codes: updated.No product was returned for analysis.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the reported issue could not be confirmed and no root cause could be found.No actions have been taken.
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Search Alerts/Recalls
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