FDA Adverse Event
Injury
Summary report: N
HYDROMID OR HYDROPICC - NOT SPECIFIED BY COMPLAINANT
MDR report key: 19202023
·
Received April 29, 2024
Report
- Report Number
- 3015060232-2024-00008
- Event Type
- Injury
- Date Received
- April 29, 2024
- Report Date
- April 29, 2024
- Manufacturer
- ACCESS VASCULAR INC.
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE COMPLAINANT REPORTED A BROKEN CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED FOLLOWING REPEATED REQUESTS FOR INFORMATION. THE CATHETER WAS NOT RETURNED. GIVEN THE LIMITED INFORMATION, IT IS NOT POSSIBLE TO INVESTIGATE THE ALLEGED COMPLAINT.
Description of Event or Problem · 0
REPORT OF A BREAK IN A CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 918909 | HYDROMID OR HYDROPICC - NOT SPECIFIED BY COMPLAINANT | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | ACCESS VASCULAR INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |