FDA Adverse Event
Other
Summary report: N
TENCKHOFF CATH T202
MDR report key: 3671915
·
Received February 20, 2014
Report
- Report Number
- 1317749-2014-00099
- Event Type
- Other
- Date Received
- February 20, 2014
- Date of Event
- February 5, 2014
- Report Date
- February 10, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
- Product Code
- FJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2014. 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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT PT REPORTED BY PHONE ABOUT PROBLEMS WITH THE CATHETER. PT WAS TREATED WITH ANTIBIOTIC PROPHYLAXIS. THE CATHETER HAD TO BE PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106500 | TENCKHOFF CATH T202 | DIALYSIS CATHETER | FJS | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL | 8888411405 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |