SMITHS MEDICAL ASD, INC. JELCO PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 306501 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No investigation or root cause analysis could be conducted given that no complaint sample was returned.Dhr review summary: no discrepancies or abnormalities relevant to the complaint.
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Event Description
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It was reported that occasionally the catheter locks too early before the entire needle is within the sheath.Polling our practitioners many of them have experienced this at one time or another.No patient injury reported.
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Manufacturer Narrative
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While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08748 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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