SMITHS MEDICAL ASD, INC. PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 306701 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A picture was received from the customer to demonstrate the reported problem.No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was not performed because the correct lot number was unknown.No root cause could be determined as the complaint could not be confirmed.No further action was required at this time as the reported event was not confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that during use, the safety feature button that retracts the intravenous (iv) needle from the catheter failed.Further information indicated that the plastic catheter would not slide off the needle using the guide, which resulted in the nurse having to pull the needle out of the catheter without the needle being retracted.No patient injury was reported.
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Search Alerts/Recalls
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