FDA Adverse Event
Malfunction
Summary report: N
RUSCH E.T. TUBE, RED RUBBER, LASERTUBUS 4MM
MDR report key: 2181167
·
Received July 7, 2011
Report
- Report Number
- 9610520-2011-00008
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 27, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: PER (B)(6) AFFILIATE: IN THE OPERATING ROOM, 5 MINS AFTER INSERTION (TEST PRIOR TO USE OK, LUBRICANT USED), THE TUBE BECAME BLOCKED AND THE VENTILATOR ALARM SOUNDED. THE PROBE WAS REMOVED AND A NEW ONE WAS SUCCESSFULLY INSERTED. NO CONSEQUENCE FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH E.T. TUBE, RED RUBBER, LASERTUBUS 4MM | ENDOTRACHEAL TUBE | BTR | TELEFLEX MEDICAL | NA | 10291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |