SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number A3307-17 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504); Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2019 |
Event Type
malfunction
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Event Description
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It was reported that catheters are slipping out of the epidural catheter connector (locking mechanism), catheter was frayed and a hole in the catheter was causing leakage.No patient injury was reported.
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Manufacturer Narrative
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No additional information was provided.No lot number was provided; therefore, a device history record (dhr) review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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