FDA Adverse Event
Malfunction
Summary report: N
ALARIS SE BURETTE ADMINISTRATION SET
MDR report key: 2243710
·
Received July 28, 2011
Report
- Report Number
- 9616066-2011-00431
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- April 6, 2011
- Report Date
- July 18, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K931550
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED TO DATE.
Description of Event or Problem · 1
THE USER REPORTED THAT DURING AN INFUSION ON A MALE CHILD, THEY IDENTIFIED A HOLE IN THE SET WHICH RESULTED IN A LEAK AND A BACKFLOW OF BLOOD. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SE BURETTE ADMINISTRATION SET | FPA | CAREFUSION CORP. | 72103E-0006 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |