SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Catalog Number C45101340-NLJ |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Udi and (510k) are unknown; no additional information was provided.This mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The sample was received opened in its original packaging.Visual inspection: the sample was visually inspected at a distance of 12 inches under normal lighting; found a hole in the bag tip.The most probable root cause of the issue was deemed to be supplier-related; bag was sent by the supplier in defective conditions and production personnel did not detect this issue during the assembly process.Action(s) taken to mitigate the reported issue(s): supplier was notified, a qalert was generated to ensure that operators verify that breathing bags are free of holes and damaged, and production personnel was notified by quality intern as awareness of the defect reported by the customer.
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Event Description
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It was reported that, immediately after opening the package, the customer noticed the end part of the anesthesia bag was torn.No patient injury was reported.
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Search Alerts/Recalls
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