Catalog Number 192-000J |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed on an international product, list number 192-000j that has a similar product distributed in the us, list number 192-000.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
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Event Description
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A customer reported while inserting the nasopharyngeal swab from the id now covid-19 2.0 test kit into a patient nose, the cotton swab head become lodged inside their nasal cavity on (b)(6) 2023.The customer reported that an otolaryngologist removed the cotton swab from the patient's nose.The customer did not report any additional details of patient harm, delay or impact in the patient's treatment.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retain kit lot m217624 during routine complaint testing lots p0848/p0847/s0658 and pn pk002546/pk002546/pk002197.No damage or defects were observed on the patient swabs.All tests were valid and performed as expected.The current overall incident rate for breaks during use nasopharyngeal swabs for lot m217624 based on the total quantity of kits distributed is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
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Event Description
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A customer reported while inserting the nasopharyngeal swab from the id now covid-19 2.0 test kit into a patient nose, the cotton swab head become lodged inside their nasal cavity on (b)(6) 2023.The customer reported that an otolaryngologist removed the cotton swab from the patient's nose.The customer did not report any additional details of patient harm, delay or impact in the patient's treatment.
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Search Alerts/Recalls
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