FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1895358
·
Received November 3, 2010
Report
- Report Number
- 2936999-2010-01300
- Event Type
- Injury
- Date Received
- November 3, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 5, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTS
- PMA / PMN Number
- K771219
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE PILOT BALLOON MALFUNCTIONED DURING A THORACOSTOMY AND LOWER LOBE OPERATION. THE CALLER REPORTED THAT THE DEFICIENCY RESULTED IN DIFFICULTY DEFLATING THE PT'S LUNG. THE END CLINICIAN ELECTED TO REMOVE THE DEVICE AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | BRONCHO-CATH ENDOBRONCHIAL TUBE | BTS | COVIDIEN, FORMERLY TYCOHEALTHCARE | 2010049135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |