FDA Adverse Event
Malfunction
Summary report: N
HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F
MDR report key: 2090187
·
Received April 11, 2011
Report
- Report Number
- 3003898360-2011-00151
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 23, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CBI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE DOCTOR REPORTED THAT THE BALLOON CANNOT BE INFLATED DURING FUNCTION TEST. DEFECT WAS DISCOVERED PRIOR TO PATIENT USE DURING INSPECTION/FUNCTIONALITY TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F | SHERI-I-BRONCH ENDOBROCHIAL TUBE | CBI | TELEFLEX MEDICAL | NA | 01F1000124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |