FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 2935881
·
Received January 30, 2013
Report
- Report Number
- 1416980-2013-02319
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 10, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K120443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) . THE SAMPLE WAS NOT AVAILABLE SO THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED RESTRICTED FLOW WHILE USING A HP MICROBORE CATH EXT SET WITH ONE-LINK NEEDLEFREE IV CONNECT IN THE ER DEPARTMENT. THE SET WAS CONNECTED TO A CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE ((B)(4)) AND AN ANGIOPATH. THE FLOW WAS RESTRICTED WHEN THEY USED A 20 OR 22 GAUGE ANGIOPATH. THERE WAS NO 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 |
|---|---|---|---|---|---|---|---|
| 40713 | ACCESS | ADMINISTRATION, SET, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTINU-FLO SOLUTION SET| ANGIOPATH |