FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1892209
·
Received October 26, 2010
Report
- Report Number
- 2936999-2010-01288
- Event Type
- Injury
- Date Received
- October 26, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTS
- PMA / PMN Number
- K771219
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVAL. WITHOUT THE ACTUAL COMPLAINT SAMPLE BEING RETURNED AND THE LOT NUMBER OF THE PRODUCT A FULL INVESTIGATION CANNOT BE CARRIED OUT. IF THE SAMPLE IS RECEIVED AT A LATER DATE AND/OR IF SIGNIFICANT INFO BECOMES AVAILABLE RELATED TO THIS REPORT, A SUMMARY WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE END CLINICIAN WAS EXPERIENCING DIFFICULTY GETTING A 4MM BRONCHOSCOPE DOWN THE TUBE. THE CALLER REPORTED THIS PARTICULAR SIZE BRONCHOSCOPE WAS USED BEFORE WITHOUT DIFFICULTY. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE THE PT WITH A LARGE SIZE ENDOBRONCHIAL TUBE. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | BRONCHO-CATH ENDOBRONCHIAL TUBE | BTS | COVIDIEN, FORMERLY TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |