FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 7 FR DL CVC, PEEL-APART INTRO W/SURECUFF
MDR report key: 3964678
·
Received May 30, 2014
Report
- Report Number
- 3006260740-2014-00274
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- April 26, 2014
- Report Date
- May 6, 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 EVAL. A LOT HISTORY REVIEW (LHR) OF HUYA0317 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT (S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
A 7 FR TUNNELED DUAL LUMEN HICKMAN CATHETER WAS INSERTED ON (B)(6) 2014. REMOVED ON (B)(6) 2014 BECAUSE PT C/O HEARING POP AFTER WHITE PORT OF CATHETER WAS FLUSHED. PT ALSO EXPERIENCED PAIN AT CATHETER SITE. CATHETER WAS NOTED TO BE PERFORATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319995 | HICKMAN 7 FR DL CVC, PEEL-APART INTRO W/SURECUFF | LJS | BARD ACCESS SYSTEMS | HUYA0317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |