FDA Adverse Event
Injury
Summary report: N
GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC
MDR report key: 3802367
·
Received February 21, 2014
Report
- Report Number
- 3006260740-2014-00074
- Event Type
- Injury
- Date Received
- February 21, 2014
- Report Date
- February 13, 2014
- Manufacturer
- C.R. BARD, INC (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K023374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REXF0677 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. BOTH COMPLAINTS FOR THIS LOT NUMBER (REXF0677) HAVE BEEN REPORTED FROM ONE (B)(6) FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE PICC END WAS FOUND IN THE BED SNAPPED ON THE BLUE CATHETER AT THE 5CM MARK. WE WERE UNABLE TO REMOVE THE REMAINING CATHETER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110025 | GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC | LJS | C.R. BARD, INC (BASD) | REXF0677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |