FDA Adverse Event
Other
Summary report: N
V-CATH 4 FR PICC
MDR report key: 2003186
·
Received February 15, 2011
Report
- Report Number
- 2925153-2011-00002
- Event Type
- Other
- Date Received
- February 15, 2011
- Report Date
- February 3, 2011
- Manufacturer
- NEO MEDICAL, INC.
- Product Code
- DQY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
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
BASED ON THE REPORTED INFO, SUBMITTED TO NEO MEDICAL ON (B)(6) 2011, THE COMPLAINANT STATES THAT 6 MIDLINES LEAKED AFTER 2 DAYS AT THE INSERTION SITE AND NEEDED TO BE REMOVED. NO REMOVAL DATES PROVIDED, COMPLAINANT STATED PT WAS NOT INJURED OR HARMED. FORM OF INTERVENTION NEEDED, WAS REMOVAL. CURRENT CONDITION OF THE PT IS GOOD. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH 4 FR PICC | V-CATH 4 FR | DQY | NEO MEDICAL, INC. | 380-78 | 1069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |