SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Catalog Number 100/860/075 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Operator of device is unknown; no additional information was received.No product was returned; thus, the failure mode reported could not be investigated and a root cause could not be determined.A device history record (dhr) review was not performed as the lot number provided was not valid.If the product is returned, this complaint will be reopened for further investigation.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, after opening the package, it was noted that the airbag was leaking.No patient injury was reported.
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Search Alerts/Recalls
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