FDA Adverse Event
Other
Summary report: N
V-CATH INTRODUCER
MDR report key: 2189690
·
Received July 25, 2011
Report
- Report Number
- 2925153-2011-00009
- Event Type
- Other
- Date Received
- July 25, 2011
- Date of Event
- April 8, 2011
- Report Date
- July 18, 2011
- Manufacturer
- NEO MED INC
- Product Code
- DYB
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WILL PROVIDE F/U WHEN "DEVICE EVAL SUMMARY" IS COMPLETED. (B)(4).
Description of Event or Problem · 1
PRODUCT WAS SOLD TO THIRD PARTY (B)(4) THROUGH (B)(4) WAS NOTIFIED THAT THERE WAS A REPORT MADE BY END USER TO (B)(4)'S SALES REP WHO IN TURN CALLED (B)(4) REGARDING "DULL NEEDLES". (B)(4)'S COMPLAINT COORD NOTIFIED (B)(4) AND THIRD PARTY (B)(4) WITH RMA#. (B)(4) REQUESTED THE COMPLAINT TO BE PLACED ON HOLD UNTIL MORE INFO COULD BE OBTAINED FROM OWENS AND MINOR. ON (B)(6) 2011, NEO MEDICAL RECEIVED THE REQUEST TO RETURN THE DULL NEEDLES AND PROCEED WITH THE COMPLAINT. PRODUCT WAS RECEIVED ON (B)(4) 2011 FOR EVAL THAT ALSO INCLUDED FROM THE END USER "COMPLAINT DATA COLLECTION REPORT" (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH INTRODUCER | BREAKAWAY NEEDLE | DYB | NEO MED INC | 350-20 | 1144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |