FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 4-LUMEN 8.5FR X 20CM
MDR report key: 3063721
·
Received April 12, 2013
Report
- Report Number
- 3006425876-2013-00048
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ARROW INTERNATIONAL , INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT IS REPORTED THIS EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THE PT WAS A (B)(6) MALE. THE INSERTION SITE WAS THE RIGHT SUBCLAVIAN VEIN. DURING INSERTION, THE NEEDLE BROKE. THE TIP OF THE INSERTED PORTION WAS VISIBLE AND THUS IT COULD BE REMOVED WITHOUT DIFFICULTY. A NEW KIT WAS OPENED AND THE CATHETER WAS PLACED SUCCESSFULLY. THERE WAS A DELAY NOTED, BUT IT WAS NOT HARMFUL TO THE PT. THERE ARE NO REPORTED PT INJURIES, COMPLICATIONS, OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158960 | CVC SET: 4-LUMEN 8.5FR X 20CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL , INC. | ZF2124329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |