FDA Adverse Event
Malfunction
Summary report: N
BROVIAC 6.6 FR SL CVC PEEL-APART INTRODUCER KIT W/SURECUFF
MDR report key: 4173070
·
Received October 10, 2014
Report
- Report Number
- 3006260740-2014-00514
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 18, 2014
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- PMA / PMN Number
- K830256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
(B)(6) 2014, THIS CATHETER WAS PLACED FOR CHEMOTHERAPY. ON (B)(6), A SUBCUTANEOUS LEAK OF MEDICAL FLUID OCCURRED. THE DOCTOR REMOVED THE CATHETER AND FOUND IT TO BE DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642613 | BROVIAC 6.6 FR SL CVC PEEL-APART INTRODUCER KIT W/SURECUFF | LJS | BARD ACCESS SYSTEMS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |