FDA Adverse Event
Malfunction
Summary report: N
4FR SL GROSHONG NXT CLEARVUE BASIS KIT W/MICROINTRO
MDR report key: 3964692
·
Received May 30, 2014
Report
- Report Number
- 3006260740-2014-00275
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 8, 2014
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- PMA / PMN Number
- K034020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REXL0608 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT (S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE END OF THE GROSHONG IS SPLIT. NO PT INJURY WAS REPORTED. THE LINE WAS PLACED IN THE LEFT BASILIC VEIN AND THERE WAS NO DIFFICULTY WITH INSERTION. THE EVENT OCCURRED AFTER FLUSHING THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320109 | 4FR SL GROSHONG NXT CLEARVUE BASIS KIT W/MICROINTRO | LJS | BARD ACCESS SYSTEMS | REXL0608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |