SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number 453600-NL |
Device Problem
Leak/Splash (1354)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/07/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the device did not pass a leak test.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
|
|
Manufacturer Narrative
|
Date of event is unknown.No information has been provided to date.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
|
|
Event Description
|
Additional information received via email on 14-march-2023.No adverse patient effects were reported by the customer.Date of event was updated from unknown to 07-feb-2023.
|
|
Manufacturer Narrative
|
No product was returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
|
|
Search Alerts/Recalls
|
|
|