FDA Adverse Event
Malfunction
Summary report: N
27CM STRAIGHT HEMOSPLIT STANDARD KIT
MDR report key: 3958878
·
Received June 26, 2014
Report
- Report Number
- 3006260740-2014-00328
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 2, 2014
- Manufacturer
- BARD ACCESS SYSTEMS INC.
- Product Code
- MSD
- PMA / PMN Number
- K033294
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 REUK0508 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER DISLOCATED. THE DEVICE WAS IMPLANTED ON (B)(6) 2011. THE USER SUPPOSED THAT THE CUFF GREW IN INCORRECTLY. NO FURTHER PROBLEMS WITH THIS CATHETER WERE NOTICED TILL THE REPORTING DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373623 | 27CM STRAIGHT HEMOSPLIT STANDARD KIT | MSD | BARD ACCESS SYSTEMS INC. | REUK0508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |