MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for CORFLO ULTRA NG FEEDING TUBE 20-7431AIV2 manufactured by Corpak Medsystems, Inc..
[116655270]
Corpak corflo enteral feeding tube guidewire and tubing kinked, unable to flush or use. Ref 20-7431aiv2, lot 79540, (b)(4). Tube removed and replaced with effective device. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7769700 |
| MDR Report Key | 7769700 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-03 |
| Report Date | 2018-08-06 |
| Date Reported to FDA | 2018-08-06 |
| Date Reported to Mfgr | 2018-08-09 |
| Date Added to Maude | 2018-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORFLO ULTRA NG FEEDING TUBE |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-08-09 |
| Model Number | 20-7431AIV2 |
| Catalog Number | 20-7431AIV2 |
| Lot Number | 79540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEMS, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |