MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-06 for SMITHS MEDICAL ANESTHESIA CIRCUIT C45101314J manufactured by Smiths Medical Asd, Inc..
[182418359]
Information was received that a smiths medical general anesthesia circuit had an air leak during a pre-use check. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01814 |
| MDR Report Key | 9801417 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-06 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A DE C.V |
| Manufacturer Street | AVE CALIDAD NO. 4 PARQUE INDUSTRIALLNTERNACIONAL |
| Manufacturer City | TIJUANA, 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL ANESTHESIA CIRCUIT |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) |
| Product Code | OFP |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-14 |
| Catalog Number | C45101314J |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |