FDA Adverse Event
Other
Summary report: N
PERIFIX
MDR report key: 288254
·
Received August 1, 2000
Report
- Report Number
- 2523676-2000-00015
- Event Type
- Other
- Date Received
- August 1, 2000
- Date of Event
- June 5, 2000
- Report Date
- July 20, 2000
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- CAZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DR PLACED A CATHETER IN PT FOR LABOR AND DELIVERY IN 2000. THE CATHETER WAS PLACED LESS THAN 24 HRS. PT WAS DISCHARGED. PT RETURNED TO EMERGENCY ROOM ON FOLLOWING WEEKEND WITH CHILLS & FEVER. PT WAS SENT HOME SINCE THE DIAGNOSIS WAS NOT CLEAR AT THAT TIME. PT RETURNED TO EMERGENCY ROOM ON TUESDAY, 6/13/2000 WITH CHILLS & FEVER, AND SOME NEUROLOGICAL SIGNS. HAD DEBRIDEMENT SURGERY AND IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERIFIX | PERIFIX CUSTOM SOFT TIP EPIDURAL TRAY | CAZ | B. BRAUN MEDICAL, INC. | CE17TKST | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |