SMITHS MEDICAL ASD, INC. PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 S; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Catalog Number 3060BR |
Device Problem
Dull, Blunt (2407)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Udi is unknown, no product 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 additional reportable information becomes available.
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Event Description
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It was reported that there was difficulty puncturing the patient with the needle, with risk of bloodstream infection and phlebitis.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other, other text: h6: health impact, event methods, evaluation, and conclusion codes: updated.No product was returned, therefore functional testing could not be conducted.A review of manufacturing device history records found no abnormalities or discrepancies that match the reported issue.Based on the available information, the investigation could not confirm the reported issue or attribute a root cause.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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