FDA Adverse Event
Other
Summary report: N
BETA CAP ADAPTER
MDR report key: 2997549
·
Received February 25, 2013
Report
- Report Number
- 1017072-2013-00007
- Event Type
- Other
- Date Received
- February 25, 2013
- Report Date
- February 22, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
- Product Code
- FJS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH BETA CAP ADAPTER. THE CUSTOMER REPORTS THE BETA CAP DISLODGED FROM THE DIALYSIS CATHETER. A CUT DOWN PROCEDURE WAS COMPLETED AND THE CATHETER WAS REPAIRED. THE PATIENT WAS GIVEN ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79339 | BETA CAP ADAPTER | BETA CAP ADAPTER | FJS | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL | 8814661001 | 212304X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |