FDA Adverse Event
Injury
Summary report: N
ALARIS EXTENSION SET
MDR report key: 1780871
·
Received July 29, 2010
Report
- Report Number
- 9616066-2010-00189
- Event Type
- Injury
- Date Received
- July 29, 2010
- Date of Event
- June 18, 2010
- Report Date
- June 29, 2010
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K790108
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PRODUCT HAS BEEN REQUESTED MULTIPLE TIMES TO BE RETURNED FOR EVAL, IT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INFO IS OBTAINED.
Description of Event or Problem · 1
CUSTOMER REPORTED TUBING FOR THE Y-CONNECTOR WAS CRACKED AND WHEN THE NURSE FLUSHED THE TUBING, THE FLUID (WHICH CONTAINED BLOOD) SPLASHED IN HER EYE. EVENT OCCURRED IN PEDIATRICS. FACILITY'S PROTOCOL WAS FOLLOWED AND USER BLOOD WORK WAS PERFORMED. NO ADDITIONAL INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS EXTENSION SET | FPA | CAREFUSION CORP. | 10794983 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |