SMITHS MEDICAL ASD, INC. PROTECTIV PLUS SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
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Model Number 306701 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2020 |
Event Type
malfunction
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Event Description
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It was reported by the user that the 20 gauge intravenous (iv) catheter failed to retract the needle, which is part of the safety feature of the product.No patient injury was reported.
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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 record (dhr) review was performed.Nonconformance data identified one in-process nonconformance potentially related to this event; however, the nonconforming product was from totes not included in the reported lot number.Non-conforming product was reworked.All remaining product was found to be acceptable.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.Operator of device is unknown.No information has been provided to date.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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