MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-12 for PORTEX ANESTHESIA CIRCUIT CA13E0/400/000JP? manufactured by Smiths Medical Asd, Inc..
[144810457]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144810458]
Information was received that a smiths medical portex anesthesia circuit set had a tear in the anesthesia bag during use. The issue was not detected during the pre-use check. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02639 |
| MDR Report Key | 8602513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-12 |
| Date of Report | 2019-05-12 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-05-12 |
| 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 G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX ANESTHESIA CIRCUIT |
| Generic Name | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) PRODUCT CODE: CAI |
| Product Code | CAI |
| Date Received | 2019-05-12 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | CA13E0/400/000JP? |
| Lot Number | 3732165 |
| Operator | HEALTH PROFESSIONAL |
| 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 NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-12 |