FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 7FR DL CVC, PEEL-APART INTRO WITH SURCE CUFF
MDR report key: 3922435
·
Received June 3, 2014
Report
- Report Number
- 3006260740-2014-00282
- Event Type
- Malfunction
- Date Received
- June 3, 2014
- Date of Event
- March 26, 2014
- Report Date
- May 12, 2014
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF HUXK0093 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FORM THIS LOT NUMBER.
Description of Event or Problem · 1
ON (B)(6) 2014 PT HAD 7FR TUNNELED DUAL LUMEN HICKMAN CATHETER PLACED. REPORTED TO (B)(4) ON (B)(4) 2014 THAT CATHETER WAS NOT FUNCTIONING PROPERLY AND CAUSING PT DISCOMFORT. WHEN REMOVED, CATHETER WAS FOUND TO HAVE SMALL HOLES IN IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323293 | HICKMAN 7FR DL CVC, PEEL-APART INTRO WITH SURCE CUFF | LJS | BARD ACCESS SYSTEMS | HUXK0093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |