FDA Adverse Event
Malfunction
Summary report: N
RUSCH ENDOBRONCHIAL TUBE, CARINA HOOK, 35F
MDR report key: 2092913
·
Received April 11, 2011
Report
- Report Number
- 1044475-2011-00043
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 22, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, 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 CUSTOMER REPORTED THAT THE WHITE BALLOON WAS LEAKING DURING FUNCTIONALITY TESTING. DEFECT WAS DISCOVERED PRIOR TO USE ON A PT DURING INSPECTION / FUNCTIONALITY TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH ENDOBRONCHIAL TUBE, CARINA HOOK, 35F | ENDOBRONCHIAL TUBE | BTR | TELEFLEX MEDICAL | NA | 0716001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |