FDA Adverse Event
Malfunction
Summary report: N
EB WHITE W/CARINA HOOK 37 FR
MDR report key: 2336894
·
Received October 31, 2011
Report
- Report Number
- 8040412-2011-00160
- Event Type
- Malfunction
- Date Received
- October 31, 2011
- Date of Event
- October 6, 2011
- Report Date
- October 17, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. A F/U REPORT WILL BE SENT WITH COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE PT HAD A LUNG INFECTION AND DETERIORATING RESPIRATORY STATUS POST OPERATIVELY. A FIBEROPTIC BRONCHOSCOPY WAS PERFORMED AND A FOREIGN BODY WAS DETECTED. THE FOREIGN BODY WAS A CARINA HOOK FROM AN ENDO-BRONCHIAL RIGHT BRONCHUS ET TUBE, THAT HAD BEEN USED IN THE OPERATING ROOM ON (B)(6) 2011 DURING AN INTERVENTION ON THE PT. THE HOOK WAS SUCCESSFULLY RETRIEVED. PT'S CURRENT MEDICAL CONDITION IS UNK. ADD'L INFO HAS BEEN REQUESTED BUT NOT RECEIVED IN TIME FOR THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EB WHITE W/CARINA HOOK 37 FR | ENDOBRONCHUS TUBE W/CARINA HOOK | BTR | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |