SMITHS MEDICAL ASD, INC. JELCO SERIVA IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Catalog Number 8357 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device was not smooth, appeared stiff, while inserting the catheter through the skin.No patient harm was reported.
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Manufacturer Narrative
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A product was received and sent to the supplier for investigation.This is a supplied item; the device history record (dhr) is at the supplier.No further information has been made available to date.Should additional information be returned pertinent to the investigation, a supplemental report will be filed.Operator of device and initial reporter also sent report to fda is unknown.No information has been provided to date.Pma/510k is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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