MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-26 for ROSS 55041 UNK manufactured by Ross Product Division, Device Call Center.
[342643]
Feeding tube clotted after crushed pills were given through it. The nurse attempted several times to clear it, finally using a 10cc syringe partially filled with coffee. After several attempts with the coffee irrigation, the tube seemed to clear. However, when the nurse released the plunger the syringe refilled with the coffee. With the syringe empty, the pt grimaced and seemed relieved when the syringe refilled. The nurse removed the tube. With repeated pressure, an aneursym was created in the tubing at the 70 cm mark. This would place the aneurysm in the pt's throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033103 |
| MDR Report Key | 556340 |
| Date Received | 2004-08-26 |
| Date of Report | 2004-08-26 |
| Date of Event | 2004-08-16 |
| Date Added to Maude | 2004-11-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROSS |
| Generic Name | DOBHOFF FEEDING TUBE |
| Product Code | BSS |
| Date Received | 2004-08-26 |
| Model Number | 55041 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | 10 FR. 45"-114CM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 546009 |
| Manufacturer | ROSS PRODUCT DIVISION, DEVICE CALL CENTER |
| Manufacturer Address | 1033 KINGMILL PARKWAY COLUMBUS OH 43229 US |
| Baseline Brand Name | FLEXIFLO ENTERAL FEEDING TUBE (10 FR 45" W/STYLET) |
| Baseline Generic Name | NASOGASTRIC FEEDING TUBE |
| Baseline Model No | 55041 |
| 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 | 2004-08-26 |