FDA Adverse Event
Malfunction
Summary report: N
SLIC COMPONENT: 7 FR X 6
MDR report key: 3080937
·
Received April 24, 2013
Report
- Report Number
- 9680794-2013-00013
- Event Type
- Malfunction
- Date Received
- April 24, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 22, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DYB
- PMA / PMN Number
- K780532
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR. THE SINGLE LUMEN COMPANION PRODUCT WAS INSERTED INTO THE INTRODUCER. WHEN THE SLIC WAS REMOVED, A CORKSCREW SHAPED PIECE OF PLASTIC CAME OUT WITH THE SLIC. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177915 | SLIC COMPONENT: 7 FR X 6 | SINGLE LUMEN CVC PRODUCTS | DYB | ARROW INTERNATIONAL INC | CF2114163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |