FDA Adverse Event
Malfunction
Summary report: N
HUBER NEEDLE EXTENSION SETWITH INTERLINK Y
MDR report key: 1901839
·
Received November 17, 2010
Report
- Report Number
- 6000001-2010-04955
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 29, 2010
- Report Date
- October 29, 2010
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K961495
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ONE ACTUAL UNIT WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO BAXTER (B)(4) A HUBER NEEDLE EXTENSION SET WITH INTERLINK Y-SITE THAT WAS INVOLVED IN A NO FLOW. ACCORDING TO THE REPORT, THE NURSE COULD NOT GET SALINE TO FLOW INTO THE SET DURING PRIMING. 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 |
|---|---|---|---|---|---|---|---|
| 1 | HUBER NEEDLE EXTENSION SETWITH INTERLINK Y | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO | FC10010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |