MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2004-03-19 for FLEXIFLO ENTERAL FEEDING TUBE 473 NA manufactured by Ross Products Div., Abbott Laboratories.
[354365]
Healthcare professional attempted to place the device but would not go "all the way down. " several attempts were made, but the device would not pass into the stomach as seen on x-ray. When the device was removed, the guidewire was sticking through the tube near the weighted end. Nursing staff was concerned that the guidewire was sticking into the pt and that was why it wasn't going down. The guidewire had not been protruding prior to insertion. A few days later, another attempt was made to place the device, but the pt began coughing up blood. The procedure was stopped and a peg tube was inserted. Nursing staff was unsure if the prior event caused any damage that might have resulted in hematemesis. The pt has recovered well and was discharged to a nursing home. One pt involved. Note: the event date given above is approximate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528738-2004-00008 |
| MDR Report Key | 516770 |
| Report Source | 01,06 |
| Date Received | 2004-03-19 |
| Date of Report | 2004-02-18 |
| Date of Event | 2004-02-18 |
| Date Mfgr Received | 2004-02-18 |
| Date Added to Maude | 2004-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | DANIEL HAMILTON |
| Manufacturer Street | 625 CLEVELAND AVE |
| Manufacturer City | COLUMBUS OH 43215 |
| Manufacturer Country | US |
| Manufacturer Postal | 43215 |
| Manufacturer Phone | 6146243743 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | * |
| Manufacturer City | SLIGO |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIFLO ENTERAL FEEDING TUBE |
| Generic Name | 78 BSS TUBE, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2004-03-19 |
| Model Number | 473 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | 510(K) K992494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 505805 |
| Manufacturer | ROSS PRODUCTS DIV., ABBOTT LABORATORIES |
| Manufacturer Address | 625 CLEVELAND AVE. COLUMBUS OH 43215 US |
| Baseline Brand Name | FLEXIFLO ENTERAL FEEDING TUBE (8 FRENCH, 45" WITH STYLET) |
| Baseline Generic Name | NASOGASTRIC FEEDING TUBE |
| Baseline Model No | 473 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | K039 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K992494 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-19 |