FDA Adverse Event
Malfunction
Summary report: N
SET, ADMINISTRATION
MDR report key: 1350834
·
Received January 21, 2009
Report
- Report Number
- 9616066-2009-00034
- Event Type
- Malfunction
- Date Received
- January 21, 2009
- Date of Event
- December 19, 2008
- Report Date
- January 5, 2009
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FPA
- PMA / PMN Number
- K022209
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 1/21/2009.
Description of Event or Problem · 1
CUSTOMER REPORTED A LEAK IN THE IV TUBING. A CRACK DEVELOPED AT ONE OF THE CONNECTIONS SITES WHERE THE CLEAR TUBING MEETS THE BLUE SEGMENT. LEAKING WAS TRACED BACK TO THE CRACK IN THE PRIMARY TUBING. NO PT HARM; NO MEDICAL INTERVENTION REPORTED. DISPOSABLE RETURN REQUESTED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET, ADMINISTRATION | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 2420-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |