FDA Adverse Event
Malfunction
Summary report: N
MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING
MDR report key: 6774831
·
Received August 8, 2017
Report
- Report Number
- 2936999-2017-05394
- Event Type
- Malfunction
- Date Received
- August 8, 2017
- Date of Event
- July 18, 2017
- Report Date
- July 18, 2017
- Manufacturer
- MMJ SA DE CV (USD)
- Product Code
- BSR
- UDI-DI
- 60884522004089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IN THIS REPORT IS PRODUCT CODE: BSR, DEVICE CLASS: 1, REGULATION NUMBER: 868.5790 (510K EXEMPT). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED A REPORT THAT THE UNIT WAS HAVING A LABELING ISSUE. IT WAS INCORRECT. THE ISSUE WAS DETECTED IN THE DISTRIBUTION CENTER, THEREFORE, THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE CUSTOMER DISCARDED THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 556278 | MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING | STYLET, TRACHEAL TUBE | BSR | MMJ SA DE CV (USD) | 85864 | 16K0104JZX | 60884522004089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |