MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-01 for PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS 482802-NL manufactured by Smiths Medical Asd, Inc..
[181656366]
Information was received that during the use of a smiths medical portex pediatric disposable anesthesia breathing circuits the bag detached from black cap and was unable to continue use. Bag replaced with new on and ventilation was continued. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01631 |
| MDR Report Key | 9772856 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-01 |
| Date of Report | 2020-03-01 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2020-03-01 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
| Manufacturer Street | AVE CALIDAD NO. 4, PARQUE INDUSTRIALINTERNACIONAL |
| 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 | PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) PRODUCT CODE: OFP |
| Product Code | OFP |
| Date Received | 2020-03-01 |
| Model Number | 482802-NL |
| Lot Number | 3739563 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-01 |