FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1821498
·
Received August 25, 2010
Report
- Report Number
- 2936999-2010-01126
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 20, 2010
- Report Date
- July 26, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K841872
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). APPLICABLE 510K# FOR US DISTRIBUTED PART IS K841872. 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 TUBE DEVELOPED A LEAK DURING PATIENT USE, BUT THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | REINF TRACH CANN SZ 7.0MM | BTR | COVIDIEN, FORMERLY TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |