FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1870864
·
Received October 6, 2010
Report
- Report Number
- 2936999-2010-01249
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 9, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTS
- PMA / PMN Number
- K771219
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 LABELING ON THE TUBE WAS INVERSED. THIS WAS DISCOVERED DURING PATIENT USE SO, THE END CLINICIAN ELECTED TO REMOVE THE TUBE AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | BRONCHO-CATH ENDOBRONCHIAL TUBE | BTS | COVIDIEN, FORMERLY TYCOHEALTHCARE | 2010049125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |