MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for AIRLIFE SFT2600 manufactured by Carefusion.
[99130581]
Patient Sequence No: 1, Text Type: N, H10
[99130582]
Open the oxygen tubing package to apply it to a patient and there was a white substance coating the tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7244792 |
| MDR Report Key | 7244792 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-12 |
| Report Date | 2017-12-13 |
| Date Reported to FDA | 2017-12-13 |
| Date Reported to Mfgr | 2017-12-13 |
| Date Added to Maude | 2018-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2018-02-06 |
| Catalog Number | SFT2600 |
| Lot Number | 0000855132 |
| ID Number | 10885403186981 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |