FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 7 FR X 20 CM
MDR report key: 2241174
·
Received August 17, 2011
Report
- Report Number
- 1036844-2011-00276
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- May 25, 2011
- Report Date
- August 12, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FOZ
- PMA / PMN Number
- K993691
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED DURING INSERTION. UPON ADVANCING THE SPRING WIRE GUIDE (SWG), THE WIRE WAS STUCK IN THE SYRINGE AND WAS UNABLE TO WITHDRAW. AS A RESULT, THE DEVICE WAS REMOVED AND NOT USED. A NEW KIT WAS OPENED AND USED WITH SUCCESS. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THERE WAS NO REPORT OF PT DEATH, COMPLICATION OR INJURY. THE PT OUTCOME IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 3-LUMEN 7 FR X 20 CM | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |