FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI KIT 23/40 CM X5
MDR report key: 3210124
·
Received June 27, 2013
Report
- Report Number
- 1317749-2013-00200
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 9, 2013
- Report Date
- June 11, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS IMPLANTED ON (B)(6) 2013. SINCE (B)(6) 2013 THE CATHETER PULLS AIR DURING DIALYSIS. THE CATHETER WAS REMOVED ON (B)(6) 2013 AND REPLACED WITH A COMPETITOR PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293090 | PALINDROME HSI KIT 23/40 CM X5 | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145048C | 128716X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |