FDA Adverse Event
Injury
Summary report: N
INTROCAN SAFETY CLOSED IV CATH
MDR report key: 14288450
·
Received May 4, 2022
Report
- Report Number
- MW5109527
- Event Type
- Injury
- Date Received
- May 4, 2022
- Date of Event
- April 30, 2022
- Report Date
- May 3, 2022
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
UPON REMOVAL OF AN #20 ANGIO IV CATHETER, NURSE NOTICED FRAYING OF THE TIP OF THE CATHETER. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565593 | INTROCAN SAFETY CLOSED IV CATH | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | B. BRAUN MEDICAL INDUSTRIES SDN. BHD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female | Required Intervention |