FDA Adverse Event
Malfunction
Summary report: N
3.5FR P.U.R. UMBIL CATH X10
MDR report key: 2241561
·
Received September 2, 2011
Report
- Report Number
- 1317749-2011-00247
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Report Date
- August 5, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FACILITY TO DATE NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. IF PERTINENT INFORMATION IS OBTAINED FROM THE FACILITY THE MEDWATCH FORM WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER. THE CUSTOMER REPORTED THE CATHETER WAS LEAKING FLUIDS, WHILE AN INFANT WAS IN THE PRONE POSITION. THE FACILITY MEDICAL STAFF WERE USING A STOP CAP AND A HEMOSTAT AROUND THAT AREA FOR PLACEMENT/CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5FR P.U.R. UMBIL CATH X10 | UVC | FOS | COVIDIEN | 8888160333 | 036509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |