MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for CORPAK 20-9368 TRAK2 manufactured by Medsystems/ Seisa Medical Inc..
[103398639]
Size 8 fr feeding tube inserted with no resistance, wire pulled out with no kinks when placement checked with syringe, unable to push any air through, patient in no distress, tube was pulled back to check no changes, patient in no distress, pushed back in unable to push any air through. Tube pulled back completely, no air able to push through the first time (tube was already outside the patient) attempted two more times then on the third time, finally able to push through air in the tube. Brand name was corpack new tube was inserted with no problems, and placement check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075996 |
| MDR Report Key | 7365207 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-21 |
| Date Added to Maude | 2018-03-23 |
| 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 | 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 | 0 |
| Brand Name | CORPAK |
| Generic Name | FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2018-03-22 |
| Model Number | 20-9368 |
| Catalog Number | TRAK2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSYSTEMS/ SEISA MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-22 |