FDA Adverse Event
Malfunction
Summary report: N
GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM) (WITH MICROINT
MDR report key: 8295269
·
Received January 31, 2019
Report
- Report Number
- 3006260740-2019-00146
- Event Type
- Malfunction
- Date Received
- January 31, 2019
- Report Date
- January 31, 2019
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- UDI-DI
- 00801741035258
- PMA / PMN Number
- K034020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF RECN0592 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED VIA MS&S PATIENT HAS A 4FR GROSHONG NXT PICC THAT BLEW WHERE IT MEETS THE CONNECTOR (PORTION WITH WRITING ON IT). THE NURSE STATED THAT WHEN ADMINISTERING CONTRAST FOR A CT ANGIOGRAM THE CATHETER BLEW. CATHETER WAS CLAMPED, BUT NEED TO KNOW IF IT IS REPAIRABLE. MS&S EXPLAINED THAT THE 4FR GROSHONG NXT CAN BE REPAIRED WITH A REPAIR KIT. MS&S EMAILED GROSHONG NXT CONNECTOR IFU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85704 | GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM) (WITH MICROINT | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | BARD ACCESS SYSTEMS | N/A | RECN0592 | 00801741035258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |