SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number C37101548 |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Event Description
|
It was reported that the adult breathing circuit was leaking.Patient involvement unknown.
|
|
Manufacturer Narrative
|
B3: date of event and d4: udi number is unknown, no information has been provided to date.G5: 510k 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
|
Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.(b)(4)devices were received in total.(b)(4)were received without their original packaging, (b)(4) of which was received without bag and (b)(4) were received with their original packaging and completely sealed.During visual inspection, it was possible to detect (b)(4) device with a broken/damaged tube, which caused the leaking failure mode; the rest of the twelve devices did not have any defects.A leak test was performed on the damaged device in which there was an air leak.The complaint was confirmed by visual inspection and functional testing.The root cause was damage caused by the improper handling of the product during its assembly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed they have been executed accordingly, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation.
|
|
Search Alerts/Recalls
|
|
|