MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-04 for RUSCH FOX POST NASAL TUBE W/SYRINGE 568000 manufactured by Teleflex Medical.
[3766070]
The complaint was reported as: the customer alleges that the tube broke during use. The tube was being used to assist with an uncontrolled nose bleed. During the placement of the tube; the red rubber on the outside of the tube leaked. An attempt was made to place a monitor over the leak and the tube broke. The pt condition is reported as fine. Intervention: a nasal pack had to be inserted to slow the bleeding. The pt condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[11221601]
A visual and functional inspection of the product involved in the complaint could not be conducted since the product is not available for eval. The lot number provided (037069-1) is invalid number, based on this no dhr (device history record) review can be performed at this time. If the lot number becomes available at a later date, the investigation will be re-opened accordingly. No corrective action can be established since the defective sample was not received for eval. No conclusion can be established at this time based on the lack of the defective sample. It is necessary to have the physical sample in order to perform a properly investigation. If the product sample becomes available this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00296 |
| MDR Report Key | 3383181 |
| Report Source | 06 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-19 |
| Date of Event | 2013-08-18 |
| Date Mfgr Received | 2013-08-19 |
| Date Added to Maude | 2013-12-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, SPECIALIST |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH FOX POST NASAL TUBE W/SYRINGE |
| Generic Name | OTOLARYNGOLOGY - EPISTAXIS AIRWAY |
| Product Code | EMX |
| Date Received | 2013-09-04 |
| Catalog Number | 568000 |
| Lot Number | 037069-1 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-04 |