FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN/PSI SET
MDR report key: 1673822
·
Received April 20, 2010
Report
- Report Number
- 1036844-2010-00105
- Event Type
- Malfunction
- Date Received
- April 20, 2010
- Date of Event
- March 30, 2010
- Report Date
- April 19, 2010
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DYB
- PMA / PMN Number
- K002507
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 WHILE USING OUR MULTI-LUMEN ACCESS CATHETER (MAC), BLOOD BEGAN TO LEAK BACK INTO THE PROTECTIVE SHIELD AS SOON AS THE SWAN-GANZ CATHETER WAS PLACED. AS A RESULT, A CATHETER EXCHANGE WAS PERFORMED OVER A SPRING WIRE GUIDE (SWG). IT WAS NOT NECESSARY TO MAKE ANOTHER INSERTION SITE. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. THE SWAN-GANZ CATHETER USED WAS A 7.5 FR. BY EDWARDS LIFE SCIENCES. ADDITIONAL INFORMATION RECEIVED ON 4/1/2010, BY THE SALES REPRESENTATIVE, STATED THAT THE INSERTION SITE IN THIS EVENT WAS RIGHT INTERNAL JUGULAR AND THE BLOOD THAT LEAKED INTO THE SHIELD WAS A "SMALL AMOUNT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN/PSI SET | MULTI-LUMEN ACCESS CATHETERS | DYB | ARROW INTERNATIONAL INC | RF9126431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | SWAN-GANZ CATHETER| EDWARDS LIFE SCIENCES |