FDA Adverse Event
Malfunction
Summary report: N
LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT
MDR report key: 4173537
·
Received October 10, 2014
Report
- Report Number
- 3006260740-2014-00509
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 2014
- Manufacturer
- BARD ACCESS SYSTEMS INC.
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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) OF REXG2001 SHOWED THREE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. ALL COMPLAINTS FOR THIS LOT NUMBER (REXG2001) HAVE BEEN REPORTED FROM TWO (B)(6) FACILITIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT SANDHOLES APPEARED AT 23CM FROM THE CATHETER AFTER IT WAS BEING USED FOR 1 MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642944 | LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT | LJS | BARD ACCESS SYSTEMS INC. | REXG2001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |