FDA Adverse Event
Other
Summary report: N
SAFESITE
MDR report key: 1003056
·
Received February 21, 2008
Report
- Report Number
- 2523676-2008-00009
- Event Type
- Other
- Date Received
- February 21, 2008
- Report Date
- February 19, 2008
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FPA
- PMA / PMN Number
- K942988
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL DEVICE A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.
Description of Event or Problem · 1
AAS REPORTED BY THE USER FACILITY: "BLOOD SPURTING OUT OF VALVE," ATTACHED TO AN EXTENSION SET. ADD'L INFO PROVIDED BY THE FACILITY INDICATED BLOOD SPURTED OUT OF THE VALVE AFTER IT WAS ACCESSED. THE NURSE IMMEDIATELY CLAMPED THE TUBING AND CHANGED THE VALVE. BLOOD LOSS WAS MINIMAL AND THE PT SUFFERED. NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFESITE | REFLUX VALVE AND CAP | FPA | B. BRAUN MEDICAL, INC. | RV1000C | 60959093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |