FDA Adverse Event
Malfunction
Summary report: N
NEO MAGIC MST KIT
MDR report key: 2276060
·
Received September 2, 2011
Report
- Report Number
- 2925153-2011-00014
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 5, 2011
- Report Date
- September 2, 2011
- Manufacturer
- NEO MEDICAL, INC
- Product Code
- LJS
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WILL PROVIDE FOLLOW-UP "DEVICE EVALUATION SUMMARY" WHEN THE EVALUATION IS COMPLETED. PENDING PRODUCT RETURN FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
WING COMPLETELY BROKE OFF FROM SHEATH ON ONE SIDE DURING PICC INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEO MAGIC MST KIT | MST KIT | LJS | NEO MEDICAL, INC | 1958-004 | 1006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |