FDA Adverse Event
Malfunction
Summary report: N
CLEARLINK LUER ACTIVATED VALVE
MDR report key: 5893537
·
Received August 22, 2016
Report
- Report Number
- 1416980-2016-14428
- Event Type
- Malfunction
- Date Received
- August 22, 2016
- Report Date
- August 22, 2016
- Manufacturer
- BAXTER HEALTHCARE-CARTAGO
- Product Code
- FPA
- PMA / PMN Number
- K112893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT OCCURRED IN (B)(6) 2016. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A NO FLOW ISSUE WITH A CLEARLINK SYSTEM EXTENSION SET. THIS OCCURRED DURING INFUSION. IT WAS STATED THAT THEY WERE HAVING SIGNIFICANT DECREASE IN FLOW OF THE WHEN THEY DO RAPID INFUSIONS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545612 | CLEARLINK LUER ACTIVATED VALVE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE-CARTAGO | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STOPCOCK |