MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUIT CA24B0/4P6/000JP manufactured by Smiths Medical Asd, Inc..
[124963283]
Information was received that during the use of a smiths medical breathing circuit, water droplets stayed in the connector for the hme filter, within the circuit ahead of the connector, and in the gas sampling line. No patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[133986092]
One photo of the device was received. Upon visual inspection of the photo, water in the circuit was confirmed. While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2018-01911 |
| MDR Report Key | 7997381 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
| Generic Name | CIRCULATOR, BREATHING-CIRCUIT |
| Product Code | CAG |
| Date Received | 2018-10-23 |
| Returned To Mfg | 2018-09-28 |
| Catalog Number | CA24B0/4P6/000JP |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-23 |