MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-19 for PATIENT GAS SAMPLING LINE, 10 FT PAC010 manufactured by Pharmaseal Div. Baxter Healthcare Corp..
[8300]
The rptr noted five gas sampling lines that were occluded in 2 days. There was no adverse pt outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001643 |
| MDR Report Key | 12809 |
| Date Received | 1994-04-19 |
| Date of Report | 1994-04-18 |
| Date of Event | 1994-04-16 |
| Date Added to Maude | 1994-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT GAS SAMPLING LINE, 10 FT |
| Product Code | CAM |
| Date Received | 1994-04-19 |
| Catalog Number | PAC010 |
| Lot Number | CR3A042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 12808 |
| Manufacturer | PHARMASEAL DIV. BAXTER HEALTHCARE CORP. |
| Manufacturer Address | DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-19 |