MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-04-22 for FLEXIFLO ENTERAL FEEDING TUBE 473 NA manufactured by Abbott Laboratories/ross Products Div.
[397892]
Reporter stated the device was found to be pulled back from the pt's left nares and the pt was found coughing and gagging. Placement marking was not documented on the device or in the chart. Feedings were held until the tube could be repositioned and checked for correct placement. Pt was confused and agitated with increasing oxygen demands and increased wbc. Medical intervention consisted of deep suction and intubation 10 days later with the pt's temperature documented at 39. 7c. The pt has since recovered. No failure or malfunction of the device was described.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528738-2005-00008 |
| MDR Report Key | 594660 |
| Report Source | 06 |
| Date Received | 2005-04-22 |
| Date of Report | 2005-04-11 |
| Date of Event | 2005-03-01 |
| Date Mfgr Received | 2005-04-11 |
| Date Added to Maude | 2005-04-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| 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 TUBES, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2005-04-22 |
| Model Number | 473 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | 510(K) K992494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES/ROSS PRODUCTS DIV |
| Manufacturer Address | 625 CLEVELAND AVE. COLUMBUS OH 43215 US 43215 |
| 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 | 2005-04-22 |