FDA Adverse Event
Malfunction
Summary report: N
HUDSON SHER-I-BROCH ENDOBRONCHIAL TUBE, 39FR
MDR report key: 1963353
·
Received December 17, 2010
Report
- Report Number
- 3003898360-2010-00516
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Report Date
- December 7, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THERE IS A FRACTURE ON THE TUBE HEAD IN THE PLASTIC PART ON THE BLUE PLUG OF THE DOUBLE-SWIVEL ADAPTOR. THE PART WAS LEAKY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON SHER-I-BROCH ENDOBRONCHIAL TUBE, 39FR | ENDOBRONCHIAL TUBE | BTS | TELEFLEX MEDICAL | NA | 01H0900197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |