FDA Adverse Event
Malfunction
Summary report: N
SECURACATH
MDR report key: 24291209
·
Received February 9, 2026
Report
- Report Number
- 24291209
- Event Type
- Malfunction
- Date Received
- February 9, 2026
- Date of Event
- January 10, 2026
- Report Date
- January 30, 2026
- Manufacturer
- INTERRAD MEDICAL, INC
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ROUTINE LINE CARE FLUSHES WERE DONE ON A TRIPLE LUMEN PICC [PERIPHERALLY INSERTED CENTRAL CATHETER]. MAINTENANCE FLUIDS WERE INFUSING THROUGH THE RED LUMEN AND DRESSING WAS CLEAN, DRY AND INTACT. HOWEVER, WHEN WE FLUSHED THE NS [NORMAL SALINE] LOCKED WHITE LUMEN, IT LEAKED SALINE FROM BENEATH THE DRESSING. WE REMOVED THE DRESSING TO INVESTIGATE, AND IT SEEMED TO BE LEAKING DIRECTLY BENEATH THE SECURE-A-CATH, SO I DID NOT OPEN THAT CASING TO INVESTIGATE FURTHER. WE RE-DRESSED THE LINE AND CONTACTED THE ON-CALL PROVIDER AND THE PICC TEAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352035 | SECURACATH | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | INTERRAD MEDICAL, INC | 5F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |