MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for NEOMED POLYURETHANE FEEDING TUBE FTL5.OP-E FTL5.OP-EO manufactured by Neomed, Inc..
[113803154]
Rn was trying to disconnect the neomed extension set with the neomed feeding tube that was inserted into patients nose and wouldn't come disconnected - attempted several times to pull apart and also the patient's father attempted to get apart and was unsuccessful - pulled again and the tubing broke off right to the plastic cap which you can't connect back up to continue feeds with. Had to insert another tube cause other one was broke. Cl aware and the tube that was removed was saved to show nurse manager. Father was at bedside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7681254 |
| MDR Report Key | 7681254 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-02 |
| Date of Event | 2017-06-29 |
| Report Date | 2018-07-02 |
| Date Reported to FDA | 2018-07-02 |
| Date Reported to Mfgr | 2018-07-12 |
| Date Added to Maude | 2018-07-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NEOMED POLYURETHANE FEEDING TUBE |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-07-12 |
| Model Number | FTL5.OP-E |
| Catalog Number | FTL5.OP-EO |
| Lot Number | 20180521 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC. |
| Manufacturer Address | 100 LONDONDERRY COURT SUITE #112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |