FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN (1
MDR report key: 1915551
·
Received November 5, 2010
Report
- Report Number
- 1036844-2010-00339
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 13, 2010
- Report Date
- November 4, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT IN RESPIRATORY DISTRESS. THE PHYSICIAN WAS TRYING TO EXCHANGE A CENTRAL VENOUS CATHETER (CVC) OVER-THE-WIRE IN THE PT'S SUBCLAVIAN WHEN THE SPRING WIRE GUIDE (SWG) WOULD NOT THREAD. AS A RESULT, IT WAS REMOVED. UPON REMOVAL, THEY NOTICED THE SWG HAD FRAYED, BUT WAS REMOVED INTACT. ADDITIONAL INFO RECEIVED FROM THE SALES REP ON 10/26/2010, STATED THEY FIRST ATTEMPTED TO INSERT THE CATHETER INTO THE PT'S RIGHT SUBCLAVIAN. IT WAS NOTED THE PT HAD MANY HEALTH COMPLICATIONS. REFERENCE MDR #1036844-2010-00340 FOR THE SECOND EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN (1 | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTL., INC. | RF0077069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |