Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device has not yet been returned and a lot number has not been provided.It is difficult to determine further that the cause of the incident is attributed to the 3m multipore dry surgical tape.
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Event Description
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An unplanned extubation occurred for a medically stable premature infant with use of 3m multipore dry surgical tape, where the tape was not staying secure.An endotracheal tube holder was used.The patient was reintubated immediately.There was no humidity in the isolette.No escalation of care was required.
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Manufacturer Narrative
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H10: the device was returned; no lot number was known.Testing of tape samples demonstrated conformance to specifications in the majority of the samples tested.While two of the samples (including the sample subject to this complaint) did test low for adhesion, overall complaint rates remain exceedingly low.Clinical best practice requires routine oversight of intubated patients to prevent issues leading to unintended extubation.Reeducation of medical tape application techniques and oversight requirements through application engineering is being offered.Testing of tape samples demonstrated conformance to specifications in the majority of the samples tested.While two of the samples (including the sample subject to this complaint) did test low for adhesion, overall complaint rates remain exceedingly low.Clinical best practice requires routine oversight of intubated patients to prevent issues leading to unintended extubation.Reeducation of medical tape application techniques and oversight requirements through application engineering is being offered.
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Search Alerts/Recalls
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