MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-05 for RUSCH MALLONEY FR28F 9213 UNKNOWN manufactured by Teleflexmedical.
[1723920]
Pt scheduled for laparoscopic roux-en-y procedure. Difficult placement of ng tube requiring placement of bougie dilator to assist in ng insertion which was final phase of operative procedure to assure no evidence of leak. Bougie was a rusch hurst style manufactured prior to 2003. Bougie was modified to assist in the insertion of the nasogastric tube. A suture was placed through one end of the dilator with a tail of suture material attached. It was discovered that the suture had apparently punctured the inner lumen of the dilator, allowing mercury to escape outside of the dilator. Frequency: 10 minutes x1. Route: nasal. Dates of use: 10 minutes. Diagnosis or reason for use: assist in placement of nasogastric tube. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5018908 |
MDR Report Key | 1957358 |
Date Received | 2011-01-05 |
Date of Report | 2011-01-05 |
Date of Event | 2011-01-04 |
Date Added to Maude | 2011-01-18 |
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 | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RUSCH MALLONEY FR28F |
Generic Name | BOUGIE |
Product Code | FAT |
Date Received | 2011-01-05 |
Model Number | 9213 |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
ID Number | UNKNOWN |
Device Expiration Date | 2011-01-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEXMEDICAL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2011-01-05 |