FDA Adverse Event Injury Summary report: N

CHECK-FLO

MDR report key: 5077311 · Received September 15, 2015

Report

Report Number
5077311
Event Type
Injury
Date Received
September 15, 2015
Date of Event
August 17, 2015
Report Date
August 17, 2015
Manufacturer
COOK, INC.
Product Code
DYB
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MD, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AN 8 FR, LARGE BORE, 6 CM CATHETER (SOMETIMES REFERRED TO AS A SHORT CORDIS CATH) WAS BEING PLACED IN A PATIENT ABOUT TO UNDERGO A LIVER TRANSPLANT. THE CATHETER WAS PLACED IN THE LEFT ANTECUBITAL. AS THEY WENT TO SECURE THE DEVICE THEY NOTED SIGNIFICANT BLEEDING AT THE INSERTION SITE. UPON INSPECTION IT BECAME CLEAR THAT THE CATHETER HUB HAD SEPARATED FROM THE CATHETER CANNULA. A TOURNIQUET WAS PLACED ON THE ARM AND EXTERNAL PRESSURE APPLIED TO HOLD THE CATHETER IN PLACE. A CUT DOWN WAS PERFORMED ON THE VEIN AND THE CATHETER RETRIEVED USING FORCEPS. GIVEN THE SIZE OF THE CATHETER THERE WAS STILL SIGNIFICANT BLEEDING AFTER 5-10 MINUTES OF PRESSURE, SO THE VEIN WAS LIGATED USING SUTURES. A PRESSURE DRESSING WAS APPLIED. THERE WAS NO REPORTED VISUAL DEFECT AT THE END OF THE CATHETER CANNULA THAT CONNECTS TO THE HUB UNTIL AFTER THE FORCEP WAS APPLIED DURING REMOVAL. THE CATHETER APPEARS TO HAVE SIMPLY SEPARATED FROM THE CATHETER HUB. THERE WERE NO REPORTED COMPLICATIONS DURING INSERTION THAT WOULD HAVE CONTRIBUTED TO THE EVENT. HAD THE CATHETER MIGRATED FURTHER SIGNIFICANT PATIENT HARM COULD HAVE OCCURRED. WE WILL CONTINUE TO MONITOR THE PATIENT'S EXTREMITY FOR ANY ADVERSE SEQUELAE. THE PACKAGING WAS NOT SAVED, HOWEVER THE OTHER CATHETERS IN STOCK IN THIS AREA HAD A LOT NUMBER OF 5890371, EXPIRATION DATE 2018-05. ONE OF THE PHYSICIANS QUESTIONED WHETHER THE GROOVED PORTION OF THE HUB JUST ABOVE WHERE THE CATHETER INSERTS MAY HAVE SOMEHOW DAMAGED THE CATHETER DURING MANUFACTURING OR FAILED TO HOLD THE CATHETER IN PLACE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
608403 CHECK-FLO CATHETER INTRODUCER DYB COOK, INC.

Patients

Seq Age Sex Outcome Treatment
1 63 YR Other| R