FDA Adverse Event
Other
Summary report: N
NA
MDR report key: 741168
·
Received July 24, 2006
Report
- Report Number
- 2647836-2006-00008
- Event Type
- Other
- Date Received
- July 24, 2006
- Date of Event
- June 9, 2006
- Report Date
- July 18, 2006
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FOZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED FOR EVAL. THIRTY TWO UNUSED SAMPLES FROM THE REPORTED LOT WERE RETURNED. THE SAMPLES WERE PHYSICALLY TESTED AND SIX SAMPLES LEAKED DUE TO A HOLE IN THE LUER TAPER OF THE CATHETER PLUG. THESE PARTS ARE MANUFACTURED AND PURCHASED FROM SMITHS MEDICAL/MEDEX INC. THE SAMPLES AND ALL AVAILABLE INFO HAS BEEN FORWARDED TO SMITHS MEDICAL/MEDEX INC. FOR EVAL.
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: LEAKING OF BLOOD AND SALINE AT CONNECTION TO CATHETER. USED IN NUCLEAR MEDICINE LAB. RADIOACTIVE SPILL. ADDITIONAL INFO RECEIVED FROM THE FACILITY INDICATED NO PT INJURY OR EXPOSURE TO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | EXTENDED IV CATHETER | FOZ | B. BRAUN MEDICAL, INC. | NA | 60812452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |