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Catalog Number NON270201 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/28/2022 |
Event Type
Injury
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Event Description
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According to the facility between (b)(6) 2022 -present the securement tape comes lose causing the preterm babies to be restuck'.
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Manufacturer Narrative
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According to the facility between '(b)(6) 2022-present the securement tape comes lose causing the preterm babies to be restuck'.Per the facility the access sites are 'secured with multiple pieces of tape and the sites are checked hourly'.Per the facility the tape is not exposed to liquid or water, however, they stated that the 'babies move around which leads them to having to replace the whole dressing causing a risk of losing the iv'.The facility stated that they've had to replace iv sites due to the tape coming lose.Per the facility the impacted patients are reporting to be fine.The sample was returned for evaluation, but a definitive root cause could not be determined.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Search Alerts/Recalls
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