FDA Adverse Event
Malfunction
Summary report: N
INTROCAN SAFETY IV CATHETER
MDR report key: 21158000
·
Received January 15, 2025
Report
- Report Number
- 21158000
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- October 15, 2024
- Report Date
- December 6, 2024
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PERIPHERAL INTRAVENOUS LINE (PIV) PLACED, VASCULAR ACCESS GAINED. ATTEMPTED TO THREAD CATHETER AND PATIENT COMPLAINED OF PAIN. UPON REMOVAL OF PIV CATHETER, IT WAS NOTED THAT TIP WAS KINKED AND WHEN FLUSHED THERE WAS A 2ND HOLE IN CATHETER. THIS REQUIRED A SECOND INTRAVENOUS LINE (IV) PLACEMENT WHICH RESULTS IN ADDITIONAL DISCOMFORT FOR THE CHILD. IV CATHETER SAVED FOR INSPECTION. BRAUN-INTROCAN SAFETY IV CATHETER, 24G REF 252500-02, EXPIRATION: 01-02-2029, LOT 24B12G8315.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 986616 | INTROCAN SAFETY IV CATHETER | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS | FOZ | B. BRAUN MEDICAL INC. | 4252500-02 | 24B12G8315 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Unknown | Other |