FDA Adverse Event
Malfunction
Summary report: N
ARTERIAL CATH SET: 20 GA X 8
MDR report key: 1915490
·
Received November 5, 2010
Report
- Report Number
- 1036844-2010-00334
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 3, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INSERTION INTO THE PT'S FEMORAL VEIN, THEY EXPERIENCED DIFFICULTY WITH THE SPRING WIRE GUIDE (SWG). AS A RESULT, IT WAS REMOVED INTACT AND THEY NOTICED IT WAS FRAYED. A SECOND KIT WAS OPENED. NO REPORTED PT COMPLICATIONS, NO PT INJURY OR DEATH. DELAY IN THERAPY UNK. REFERENCE MDR #1036844-2010-00335 FOR THE SECOND EVENT AND MDR #1036844-2010-00336 FOR THE THIRD EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTERIAL CATH SET: 20 GA X 8 | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTL., INC. | RF8016340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |