FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3914322
·
Received July 3, 2014
Report
- Report Number
- 1416980-2014-21574
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Report Date
- June 11, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- PMA / PMN Number
- K123868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INTERLINK SYSTEM BASIC SOLUTION SET LEAKED FROM ¿RIGHT ABOVE THE LUER¿. THIS OCCURRED DURING SETUP FOR PATIENT INFUSION AND PRIOR TO PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390530 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |