FDA Adverse Event
Malfunction
Summary report: N
PLEUR-EV PE SAHARA DRY SUC/SEAL CONT REINF LF6
MDR report key: 2191554
·
Received July 20, 2011
Report
- Report Number
- 3004365956-2011-00287
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CHEST DRAIN WAS NOT EVACUATING AND THE AIR/FLUID LEAKED INTO THE PT'S PLEURA SPACE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLEUR-EV PE SAHARA DRY SUC/SEAL CONT REINF LF6 | DRY SUC/SEAL CONT REINF | BTR | TELEFLEX MEDICAL | NA | 02C1000191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |