MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-06-10 for FLEXIFLO ENTERAL FEEDING TUBE 473 NA manufactured by Ross Products Div, Abbott Labs.
[379551]
Device was inserted and chest x-ray done to confirm placement. The stylet was left in place during the x-ray. X-ray verified the tube was not in the stomach. Tube was removed. Observed a hole in the tube and the stylet was protruding out of the side of the tube. There was no illness, injury or medical intervention resulting from the event. One pt involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528738-2004-00033 |
| MDR Report Key | 594067 |
| Report Source | 05,06 |
| Date Received | 2004-06-10 |
| Date of Report | 2004-05-13 |
| Date of Event | 2004-04-13 |
| Date Mfgr Received | 2004-05-13 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-04-25 |
| 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 AVENUE |
| Manufacturer City | COLUMBUS OH 43215 |
| Manufacturer Country | US |
| Manufacturer Postal | 43215 |
| Manufacturer Phone | 6146243743 |
| Manufacturer G1 | ABBOTT LABS |
| Manufacturer Street | * |
| Manufacturer City | COLUMBUS OH 43225 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43225 |
| 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 | 2004-06-10 |
| Returned To Mfg | 2004-05-05 |
| Model Number | 473 |
| Catalog Number | NA |
| Lot Number | 13-972-GD |
| ID Number | 510(K) K992494 |
| Device Expiration Date | 2007-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 583894 |
| Manufacturer | ROSS PRODUCTS DIV, ABBOTT LABS |
| 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. Other | 2004-06-10 |