FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3182264
·
Received June 21, 2013
Report
- Report Number
- 1416980-2013-16138
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- May 29, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K120443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER; THEREFORE, AN EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A ONE-LINK NEEDLEFREE NON DEHP FREE CATHETER SET EXPERIENCED BLOOD REFLUX INTO THE LINE. THIS OCCURRED DURING PATIENT INFUSION. THE REPORTER STATED THAT BLOOD BACKED UP IN THE TUBING FROM THE HUB OF THE NEEDLE TO THE REPORT. THERE WAS NO BLOOD LOSS TO THE PATIENT AND NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281856 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |