FDA Adverse Event
Other
Summary report: N
V-CATH
MDR report key: 2026230
·
Received March 14, 2011
Report
- Report Number
- 2925153-2011-00004
- Event Type
- Other
- Date Received
- March 14, 2011
- Date of Event
- January 5, 2011
- Report Date
- March 4, 2011
- Manufacturer
- NEO MEDICAL, INC.
- Product Code
- DQY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS ASSESSED AND DETERMINED TO BE A MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. (B)(4).
Description of Event or Problem · 1
COMPLETE REPORT HAS NOT BEEN REC'D BY COMPLAINANT TO DATE. A BRIEF DESCRIPTION OF THE PROBLEM WAS NOTED ON HOSPITALS INTERNAL REPORT # (B)(4) AS NOTED: "CATHETER PLACED IN PAT AND WHEN FLUSHED W/SALINE THE WITH SALINE THE SALINE SPRANG LIKE A HYDRANT FROM ONE POINT IN THE CATHETER". ALSO NOTED: THE AFFECT ON PT WAS NONE. ADD'L INFO REGARDING THE ADVERSE EVENT HAS BEEN REQUESTED TO (B)(6) HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | V-CATH 3.9FR DL PICC | DQY | NEO MEDICAL, INC. | 3981-2650 | 1001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |