FDA Adverse Event
Malfunction
Summary report: N
NAVILYST MEDICAL
MDR report key: 3221486
·
Received July 2, 2013
Report
- Report Number
- 1317056-2013-00023
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- NAVILYST MEDICAL
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH IT HAS BEEN INDICATED THAT NO SAMPLE WILL BE RETURNED TO NAVILYST MEDICAL FOR EVALUATION, THE INVESTIGATION INTO THIS EVENT IS STILL ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED, ((B)(4)).
Description of Event or Problem · 1
AS REPORTED BY SUER OF NAVILYST MEDICAL CONVENIENCE KIT USED FOR LEFT HEART CATHETERIZATIONS, DURING PREP AND DURING PROCEDURES THEY EXPERIENCED INSTANCES OF AIR BUBBLES VISIBLE OFF THE PORT OF THE MANIFOLD TO WHICH THE FLUID DELIVERY SET IS CONNECTED. ACTION TAKEN BY THE PHYSICIAN WAS DESCRIBED AS "TRIED REPEATEDLY TO BANG MANIFOLD TO REDUCE BUBBLES." NO AIR WAS INJECTED AND NO PATIENT INJURIES OCCURRED. USED DEVICES WERE DISCARDED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300500 | NAVILYST MEDICAL | CONVENIENCE KIT | DQX | NAVILYST MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |