SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EXPANDABLE BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number C45101340-NLJ |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during the pre-use check, leakage of air from the product was observed.No patient injury or adverse effects gave been reported.It was reported that no additional information is available for this complaint.
|
|
Manufacturer Narrative
|
Other text: b3: month and year of event have been provided, day is unknown.D4: udi section is unknown, no information is available.G5: 510k number is blank, device is exempt.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.
|
|
Manufacturer Narrative
|
One photo of the device and one sample of the device were received for investigation.During visual inspection, no damage or anomalies were observed on the device.The device was functionally tested, and no leakage was observed.A review of the manufacturing device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with the reported lot of products.Based on the available information, the investigation could not confirm the reported complaint or assign a root cause.No actions have been assigned at this time.
|
|
Search Alerts/Recalls
|
|
|