FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3241143
·
Received July 22, 2013
Report
- Report Number
- 1416980-2013-19311
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Report Date
- June 27, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET?S ROTATING COLLAR WAS BROKEN. THIS WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU). THE COLLAR WAS DISCOVERED TO BE BROKEN AFTER PRIMING WHEN THE USER WAS CONNECTING THE SET TO THE IV CATHETER. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE HAS BEEN NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340369 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN IV CATHETER |