FDA Adverse Event
Malfunction
Summary report: N
VARADY PHLEBOEXTRACTOR
MDR report key: 8580692
·
Received May 4, 2019
Report
- Report Number
- 8010099-2019-00005
- Event Type
- Malfunction
- Date Received
- May 4, 2019
- Date of Event
- April 5, 2017
- Report Date
- May 4, 2019
- Manufacturer
- MEDICON E.G.
- Product Code
- GDI
- UDI-DI
- 04046826015213
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. MAGNIFIED VISUAL INSPECTION OF THE DEVICE SHOWED THAT IT HAD BEEN BENT SEVERAL TIMES. THIS DOES NOT CONFORM TO BEST PRACTICES FOR THE DEVICE, WHICH IS NOT INTENDED TO BE BENT. THE FRACTURED SURFACE REVEALED A STRUCTURE TYPICAL OF FORCEFUL BREAKAGE, INDICATING APPLICATION OF UNDUE FORCE AS THE MOST PROBABLE CAUSE OF THIS EVENT. [(B)(4)].
Description of Event or Problem · 1
THE DEVICE TIP BROKE OFF DURING CLINICAL USE AND WAS IMMEDIATELY REMOVED FROM THE OPERATIVE FIELD. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374063 | VARADY PHLEBOEXTRACTOR | PHLEBOEXTRACTOR | GDI | MEDICON E.G. | 753W | 04046826015213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |