FDA Adverse Event
Malfunction
Summary report: N
VELANO VASCULAR Q2 EXTENSION SET
MDR report key: 9211430
·
Received October 18, 2019
Report
- Report Number
- 1649914-2019-00051
- Event Type
- Malfunction
- Date Received
- October 18, 2019
- Report Date
- October 18, 2019
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- FPA
- PMA / PMN Number
- K182897
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT SAMPLE WAS EVALUATED AND LEAKING WAS CONFIRMED. A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE SEEN. LEAK TESTING IS CONDUCTED AS PART OF THE MANUFACTURING PROCESS FOR THE DEVICE. THE ROOT CAUSE OF THE LEAKING IS UNKNOWN. QUEST MANUFACTURES BULK NON-STERILE OF THIS DEVICE WHICH IS SOLD TO OEM FOR FURTHER PROCESSING AND DISTRIBUTION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING AN ALLEGED INCIDENT ENCOUNTERED DURING USE OF THE DEVICE. THE REPORT STATES THAT BLOODY LEAKING WAS OBSERVED DURIN USE. A NEW DEVICE WAS USED AND NO FURTHER LEAKING WAS SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1005842 | VELANO VASCULAR Q2 EXTENSION SET | IV EXTENSION SETS | FPA | QUEST MEDICAL, INC. | 95906BNS | 058115 OR 058116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |