SMITHS MEDICAL ASD, INC. JELCO PROTECTIV PLUS W SAFETY I.V. CATHETER WINGED; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Catalog Number 308300 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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No product sample was received; therefore, visual and functional testing could not be performed.A device history review (dhr) was performed, and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.
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Event Description
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It was reported that clinicians are having issues with blown veins.The catheter is able to be inserted and threaded; however, when the catheter is flushed, the vein is blown.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: 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 3012307300-2022-07526 is no longer considered reportable, please disregard any mdr reports associated with it.
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