BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 7N8399 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930)
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Event Date 01/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported a patient experienced a central line-associated bloodstream infection (clabsi) related to the one-link device.Thirteen days prior to the event, the patient was admitted to the hospital for an unrelated condition.On the day of the event, the patient manifested a fever.On an unknown date, the patient was treated with unspecified antibiotics (drug names, doses, routes, frequencies, and durations) for clabsi.Patient recovery status was not reported.No additional information is available.
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Manufacturer Narrative
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As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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A product use review was conducted with the hospital by baxter clinical services.The assessment revealed that scrubbing (antiseptic) of the device was not performed according to the package label instructions.It was stated in the assessment result, that ¿no scrubbing was performed when the device was removed from the packaging and in between multiple syringe accesses¿.Upon further review, it was determined that the reported condition of ¿central line associated blood stream infection (clabsi)¿ was due to use error and therefore, not a manufacturing related issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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