FDA Adverse Event
Injury
Summary report: N
B. BRAUN MEDICAL INC
MDR report key: 2192930
·
Received February 1, 2008
Report
- Report Number
- 2192930
- Event Type
- Injury
- Date Received
- February 1, 2008
- Date of Event
- January 7, 2008
- Report Date
- February 1, 2008
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- NGT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT CARDIAC SURGERY. ON (B)(6) 2008, PATIENT DEVELOPED LEUKOCYTOSIS AND BLOOD CULTURES TESTED POSITIVE FOR SERRATIA MARCESCENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | B. BRAUN MEDICAL INC | HEPARIN AND NORMAL SALINE PRE-FILLED FLUSHE | NGT | B. BRAUN MEDICAL INC. | NDC# 64054-1003-02 | ||
| 2 | B. BRAUN MEDICAL INC | HEPARIN AND NORMAL SALINE PRE-FILLED FLUSHE | NZW | B. BRAUN MEDICAL INC. | NDC# 6405-0910-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |