FDA Adverse Event
Malfunction
Summary report: N
4FR V-CATH PICC SELDINGER
MDR report key: 4392415
·
Received November 21, 2014
Report
- Report Number
- 3007207906-2014-00002
- Event Type
- Malfunction
- Date Received
- November 21, 2014
- Date of Event
- September 9, 2014
- Report Date
- November 18, 2014
- Manufacturer
- NEO MEDICAL INC.
- Product Code
- DQO
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT C-2014-00009-(B)(4) WAS ASSESSED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. ADDITIONAL INFO WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND A COMPLETED COMPLAINT. INVESTIGATION ANALYSIS (B)(4) HAS BEEN COMPLETED. INCLUDED IN THIS REPORT FILING IS: MEDWATCH 3500A REPORT#: 300720796-2014-00002 AND DISCLAIMER.
Description of Event or Problem · 1
FOUND LEAK BY CLAMP (SMALL HOLE) NOTICED AFTER LINE WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758702 | 4FR V-CATH PICC SELDINGER | 4FR V-CATH | DQO | NEO MEDICAL INC. | 4029-1660 | 1057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |