FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 5.5 FR X 13 CM
MDR report key: 2193422
·
Received July 13, 2011
Report
- Report Number
- 1036844-2011-00226
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 11, 2011
- 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). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE END USER HAD CONTACTED RUSCH AUSTRIA OF A REPORT TO THE COMPETENT AUTHORITY AGES. THE DESCRIPTION OF THE EVENT WAS "GUIDEWIRE DEFECTIVE." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 STATES THE CATHETER WAS PLACED OVER THE SPRING WIRE GUIDE (SWG). WHEN THE SWG WAS TO BE REMOVED, IT WAS NOT POSSIBLE. THE SWG UNRAVELED. THE CATHETER AND SWG WERE REMOVED IN ONE PIECE. THERE WERE NO MORE DETAILS TO BE MADE KNOWN OF THIS EVENT. IT WAS INDICATED THAT THERE WERE NO FURTHER PT INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 3-LUMEN 5.5 FR X 13 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | RF0061344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |