FDA Adverse Event
Malfunction
Summary report: N
CLJ INNER TUBE #6 W/TUCKER VALVE
MDR report key: 1928223
·
Received November 15, 2010
Report
- Report Number
- 1044475-2010-00146
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE DEVICE HAS NOT BEEN RECEIVED, THEREFORE THE INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: CUSTOMER REPORTED THAT THE FLAP ON THE INNER TUBE WAS LOOSE AND WHEN CLEANED, FELL OFF. IT WAS ALSO REPORTED THE PART WHERE THE FLAP FELL OFF WAS CORRODED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLJ INNER TUBE #6 W/TUCKER VALVE | LARYNGECTOMY INNER TUBE | BTR | TELEFLEX MEDICAL | NA | TT8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |