FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 5 FR X 13 CM
MDR report key: 3972927
·
Received April 28, 2014
Report
- Report Number
- 1036844-2014-00198
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- March 7, 2014
- Report Date
- April 21, 2014
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN ER-PEDIATRICS DURING INSERTION, THE USER NOTED THAT THE SWG KINKED AND A RESULT NEEDED TO BE REMOVED ALONG WITH THE CATHETER. THE PATIENT WAS A ONE YEAR OLD MALE REQUIRING CENTRAL ACCESS DUE TO SUPRAVENTRICULAR TACHYCARDIAL THE PUNCTURE SITES WERE THE SUBCLAVIAN AND FEMORAL VEINS. A NEW KIT WAS OPENED AND USED, HOWEVER THERE WERE NO REPORTED COMPLICATIONS OR DEATH TO THE PATIENT. A TOTAL OF FOUR EVENTS OCCURRED. THE OTHER THREE EVENTS ARE MDRS 1036844-2014-00195, 1036844-2014-00196, AND 1036844-2014-00197.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253623 | CVC SET: 2-LUMEN 5 FR X 13 CM | PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF3027143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |