MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-02-20 for ONE WAY VALVE 001800 manufactured by Cardinal Health.
[307425]
One way valve not working. Block, pt burns "traceo" level.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00017 |
| MDR Report Key | 444119 |
| Report Source | 08 |
| Date Received | 2003-02-20 |
| Date of Report | 2003-02-20 |
| Date of Event | 2003-01-19 |
| Date Added to Maude | 2003-02-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | CERRADA VIA PRODUCCION #85 |
| Manufacturer City | MEXICALL |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE WAY VALVE |
| Generic Name | ONE WAY VALVE |
| Product Code | CBP |
| Date Received | 2003-02-20 |
| Model Number | 001800 |
| Catalog Number | 001800 |
| Lot Number | Y9K0601 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 433097 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Baseline Brand Name | ONE WAY VALVE |
| Baseline Generic Name | ONE WAY VALVE |
| Baseline Model No | 001800 |
| Baseline Catalog No | 001800 |
| Baseline ID | NA |
| Baseline Device Family | ACCESSORY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790151 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-02-20 |