FDA Adverse Event
Malfunction
Summary report: N
PERITONEAL CATHETER KIT 62CM
MDR report key: 2076381
·
Received April 25, 2011
Report
- Report Number
- 1317749-2011-00143
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 21, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 04/25/2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT DURING THE INJECTION OF DIALYSIS FLUID, THE NURSE NOTICED THAT THE CATHETER HAD SEVERAL MICRO-PERFORATIONS. THE NURSE SHORTENED THE CATHETER AND THE PT WAS GIVEN A TREATMENT OF ANTIBIOTICS, USUAL IN THE EVENT OF LINE BREAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERITONEAL CATHETER KIT 62CM | PERITONEAL DIALYSIS CATHETER | FJS | COVIDIEN | 8817278006 | 835534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |