FDA Adverse Event
Malfunction
Summary report: N
MALLINCKRODT
MDR report key: 4221093
·
Received November 3, 2014
Report
- Report Number
- 2936999-2014-00954
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 2, 2014
- Report Date
- October 7, 2014
- Manufacturer
- COVIDIEN
- Product Code
- BTR
- PMA / PMN Number
- K090352
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE NUMBER: (B)(4). THE FAILURE MODE WAS CONFIRMED IN THE SAMPLE RECEIVED AND WAS FOUND TO BE RELATED TO A MANUFACTURING ISSUE. A QUALITY ALERT WAS INITIATED AND TRAINING WAS PROVIDED.
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED BUT NOT RETURNED. COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER STATING THAT PRIOR TO USE, A DOCTOR FOUND A CRACK ON AN ENDOTRACHEAL TUBE WHERE THE 15 MM CONNECTOR INSERTS INTO THE TUBE. PICTURES FROM THE CUSTOMER DO SHOW A SPLIT IN THE TUBE AS DESCRIBED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702359 | MALLINCKRODT | TRACHEAL TUBE | BTR | COVIDIEN | 14D0065JZX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |