FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI KIT 23/40 CM X5
MDR report key: 2663316
·
Received July 10, 2012
Report
- Report Number
- 1317749-2012-00149
- Event Type
- Malfunction
- Date Received
- July 10, 2012
- Date of Event
- March 23, 2012
- Report Date
- June 26, 2012
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THE VENATRAC SNAPPED DURING LINE INSERTION INTO THE LIJ. MEDICAL INTERVENTION WAS REQUIRED, THE LINE WAS REWIRED AND REMOVED AND A NEW LINE WAS INSERTED. THERE WAS NO DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME HSI KIT 23/40 CM X5 | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145048C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |