FDA Adverse Event
Malfunction
Summary report: N
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
MDR report key: 6136589
·
Received November 30, 2016
Report
- Report Number
- 1416980-2016-17831
- Event Type
- Malfunction
- Date Received
- November 30, 2016
- Report Date
- November 30, 2016
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K132734
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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 WERE AIR BUBBLES IN THE TUBING OF A ONE-LINK CATHETER EXTENSION SET. THE CUSTOMER STATED THAT THE AIR APPEARED TO BE LEAKING INTO THE SET "AT THE CONNECTION SITE.¿ THIS WAS OBSERVED WHILE DRAWING BLOOD FOR LAB TESTING. THE DEVICE WAS BEING USED WITH A NON-BAXTER CATHETER. 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 |
|---|---|---|---|---|---|---|---|
| 785336 | EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BD INSYTE CATHETER WITH BLOOD CONTROL VALVE |