SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C1034J |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A product sample was received and is awaiting evaluation and investigation 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.G5 and the udi section of d4 are unknown, no product information has been provided to date.
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Event Description
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It was reported that during the pre-use air leak check, leakage was detected.No patient injury was reported.
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Manufacturer Narrative
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Device evaluation: one sample was returned for evaluation; the sample was received in used conditions without original package.The complaint returned unit was visually inspected under normal conditions of illumination to detect conditions that could cause the failure mode.The sample presents a tier damage (hole) in the circuit which confirms the failure mode reported.Sample was submitted to leak test inspection.The circuit was connected and failed the test, the failure mode was confirmed.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding and assembly process, therefore the damage (hole) was after the product left the facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.The root cause was unknown.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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