FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1821506
·
Received August 25, 2010
Report
- Report Number
- 2936999-2010-01125
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 21, 2010
- Report Date
- July 26, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- CBI
- PMA / PMN Number
- K771219
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE SAMPLE ANALYSIS, 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 BRONCHIAL LUMEN SEPARATED FROM THE Y CONNECTOR OF THE TUBE DURING PATIENT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE TUBE WAS REPLACED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | BRONCO-CATH ENDOBRONCHIAL TUBE | CBI | COVIDIEN, FORMERLY TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |