FDA Adverse Event
Malfunction
Summary report: N
STOPCOCK, 3-WAY W/ROTATING LOCK
MDR report key: 2822095
·
Received October 9, 2012
Report
- Report Number
- 9616066-2012-00714
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Report Date
- September 24, 2012
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K051499
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WAS SAVED FOR INVESTIGATION. ROOT CAUSE FOR THE REPORTED COMPLAINT IS UNK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE DIAL ON THE STOPCOCK LEAKS ALL THE TIME AND WHEN THEY TURN THE DIAL, SOMETIMES FLUID SPRAYS ON THE PT. LEAKING OCCURS DURING NORMAL USE. NO PT OR STAFF WERE HARMED. THERE IS NO REPORT OF MEDICAL INTERVENTION. NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STOPCOCK, 3-WAY W/ROTATING LOCK | FPA | CAREFUSION CORP | M4020 | 12016864 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |