FDA Adverse Event
Other
Summary report: N
1943-1640
MDR report key: 2108696
·
Received May 9, 2011
Report
- Report Number
- 2925153-2011-00007
- Event Type
- Other
- Date Received
- May 9, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 6, 2011
- Manufacturer
- NEO MEDICAL, INC.
- Product Code
- LJS
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE OF THE PRODUCT IN QUESTION HAS BEEN RECEIVED FOR EVALUATION AND SENT FOR STERILIZATION. THE DEVICE WILL BE EVALUATED BY R&D (B)(4). A COMPLAINT INVESTIGATION REPORT ((B)(4)) WILL BE COMPLETED AND SUBMITTED AS ADDITIONAL INFORMATION.
Description of Event or Problem · 1
ON (B)(4) 2011, CATHETER BEGAN TO BULGE DURING FLUSHING 3 DAYS AFTER INSERTION. EIGHT DAYS AFTER INSERTION, CATHETER BROKE AT THE SPOT WHERE IT HAD BEEN BULGING. THE VAT ATTEMPTED TO DO A CATHETER EXCHANGE BUT WERE UNSUCCESSFUL. CATHETER WAS REMOVED WITHOUT FURTHER INCIDENCE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1943-1640 | NEO MAGIC PICC | LJS | NEO MEDICAL, INC. | 1943-1640 | 1009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |