SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number 670904 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Udi and operator of deviceare unknown.No information has been provided to date.Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that 9 breathing circuits were pulled by the or (operating room) staff because they have a severe pinch on one side of the circuit arm".The staff don't want to use them in case they have a hole in it.Communicated lot numbers are: 4287195 (7 each) and 4295379 (2 each).They were discovered upon opening.No patient involvement and no patient injury were reported.
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Manufacturer Narrative
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Other, other text: h6: health impact and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found damage (flat) in the circuit which confirm the failure mode reported.The root cause of the issue could not be determined since the failure reported could not be reproduced using the tools from molding, assembly and packaging process.Therefore the damage (flat) was after the product left facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(6).
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Search Alerts/Recalls
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