MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-05-12 for ANDERSEN AN 10.11 AN 10S manufactured by Andersen Products, Inc..
[448018]
Successful insertion of andersen tube. Stylet broke approximately 4-5 inches from end of tube when attempting to remove the stylet from the nasogastric tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1053825-2006-00001 |
| MDR Report Key | 715782 |
| Report Source | 06,07 |
| Date Received | 2006-05-12 |
| Date of Event | 2006-04-10 |
| Date Mfgr Received | 2006-04-13 |
| Date Added to Maude | 2006-05-19 |
| 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 Street | 3202 CAROLINE DRIVE HEALTH SCIENCE PARK |
| Manufacturer City | HAW RIVER NC 27258 |
| Manufacturer Country | US |
| Manufacturer Postal | 27258 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANDERSEN |
| Generic Name | NASOGASTRIC TUBE |
| Product Code | BSS |
| Date Received | 2006-05-12 |
| Returned To Mfg | 2006-04-27 |
| Model Number | AN 10.11 |
| Catalog Number | AN 10S |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 704853 |
| Manufacturer | ANDERSEN PRODUCTS, INC. |
| Manufacturer Address | 3202 CAROLINE DR., HAW RIVER NC 27258 US |
| Baseline Brand Name | ANDERSEN |
| Baseline Generic Name | NASOGASTRIC TUBE |
| Baseline Model No | AN 10.11 |
| Baseline Catalog No | AN 10S |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-12 |