SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC
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Catalog Number 1720-AI |
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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The visual analysis of the retuned samples didn't show any anomaly.The needles were sharp, and the bevels were in compliance with the internal specification.The values are in compliance with the internal specification.On the basis of the results achieved, there is no evidence that the unused unit did not comply with the internal specification.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No information is provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that the needles bevel is too sharp and lead to vein's cut and difficulties to insert the mandrel.Additionally, it was reported that the safety system is too fast.No patient injury was reported.
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Search Alerts/Recalls
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