FDA Adverse Event
Malfunction
Summary report: N
PILLING CLJ INNER TUBE #5 W/TUCKER VALVE
MDR report key: 3886144
·
Received January 29, 2014
Report
- Report Number
- 1044475-2014-00015
- Event Type
- Malfunction
- Date Received
- January 29, 2014
- Date of Event
- June 1, 2013
- Report Date
- January 14, 2014
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE SAMPLE RECEIVED BY MFR BUT INVESTIGATION STILL UNDERWAY AT THIS TIME.
Description of Event or Problem · 1
FLAP FROM VALVE BROKE OFF DURING USE. NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62882 | PILLING CLJ INNER TUBE #5 W/TUCKER VALVE | METAL TRACH TUBE | BTR | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |