SECURACATH
Received Jan 17, 2019 · Event occurred Dec 17, 2018
Report 3007795799-2019-00001 · MDR key 8259056
Device
Generic name
Subcutaneous Engineered Stabilization Device
Manufacturer
Interrad MedicalModel number
SCR-01Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO DEVICES WERE RETURNED AND VERY MINIMAL INFORMATION IS KNOWN ABOUT THE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED ABOUT THE EVENTS TO AID IN DETERMINING WHAT CONTRIBUTING FACTORS WERE INVOLVED IN THE CATHETER FAILURES. BASED ON WHAT WAS REPORTED, ONLY ONE OF THE CATHETER FAILURES OCCURRED "NEAR" THE SECURACATH, MEANING THE OTHER CATHETER FAILURE WAS AWAY FROM THE SECURACATH AND THEREFORE NOT A CONTRIBUTING FACTOR TO THE CATHETER FAILURE. EXTENSIVE TESTING HAS BEEN DONE ON BARD POWERPICCS THAT SHOWS THAT THE SECURACATH DEVICE DOES NOT CAUSE LEAKS IN CATHETERS EVEN WHEN PLACED FOR EXTENDED LENGTH OF TIME. CATHETERS ARE KNOWN TO LEAK WITHOUT THE USE OF SECURACATH AND IT IS LIKELY THESE CATHETERS COULD HAVE LEAKED WITHOUT THE USE OF SECURACATH. BASED ON PREVIOUS INVESTIGATIONS, LEAKS OCCUR BECAUSE OF EXTRUSION/MATERIAL DEFECTS IN THE CATHETER OR GROSS MISUSE OF THE CATHETER. THESE CATHETER FAILURES WERE LIKELY UNRELATED TO THE USE OF SECURACATH AND MOST LIKELY CAUSED BY EXTRUSION/MATERIAL DEFECTS IN THE CATHETER OR MISUSE OF THE CATHETER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO COLLECT MORE INFORMATION WITHOUT SUCCESS. IF RELEVANT INFORMATION IS COLLECTED THAT ALLOWS FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
PICC LINE SERVICE LEAD INFORMED MANUFACTURER REPRESENTATIVE THAT "WE HAVE HAD 2 REPORTABLE PICC LINES WITH A HOLE IN, WITH ONE NEAR TO THE SECURACATH LOCATION". THE PICC LINES WERE BARD POWERPICC SOLO OF UNKNOWN SIZE.