FDA Adverse Event
Other
Summary report: N
O-Z COIL SPECIAL (OZ C CA2)
MDR report key: 3853768
·
Received June 2, 2014
Report
- Report Number
- 1317749-2014-00244
- Event Type
- Other
- Date Received
- June 2, 2014
- Date of Event
- May 26, 2014
- Report Date
- May 26, 2014
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CUFF GOT LOOSE AND DIDN'T ADHERE TO THE SKIN. AS A RESULT, THE PT SHOWED SIGNS OF A CLEAR INFECTION AT THE EXIT SITE. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ON 05/19/2014. MEDICAL INTERVENTION: ANTIBIOTICS AND A CATHETER CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322515 | O-Z COIL SPECIAL (OZ C CA2) | DIALYSIS CATHETER | MSD | COVIDIEN | 8888425710 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening |