FDA Adverse Event
Malfunction
Summary report: N
SET, ADMINISTRATION
MDR report key: 1374022
·
Received February 12, 2009
Report
- Report Number
- 9616066-2009-00082
- Event Type
- Malfunction
- Date Received
- February 12, 2009
- Report Date
- September 10, 2008
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
CUSTOMER REPORTED IV SET WITH HOLE IN THE PUMPING SEGMENT OF TUBING THAT ATTACHES TO THE HARD BLUE PLASTIC UPPER FITMENT. THE DEVICE ALARMED, THE USER OPENED THE PUMP AND NOTED THE HOLE AND LEAK. NO PT HARM WAS REPORTED. EVENT OCCURRED IN AUGUST, NO SPECIFIC DATE REPORTED. THE INVESTIGATION CONFIRMED A TEAR IN THE PUMPING SEGMENT. THE HOLE RESULTED IN THE SILICONE SEGMENT LEAKING IMMEDIATELY. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.
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 |