FDA Adverse Event
Malfunction
Summary report: N
SIL R ANG THORACIC 32FR
MDR report key: 3180179
·
Received June 4, 2013
Report
- Report Number
- 1282497-2013-00021
- Event Type
- Malfunction
- Date Received
- June 4, 2013
- Date of Event
- April 1, 2013
- Report Date
- May 7, 2013
- Manufacturer
- COVIDIEN
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A THORACIC CATHETER. THE CUSTOMER STATED THAT UPON INSERTION OF THE RIGHT ANGLE THORACIC CATHETER IT SNAPPED IN HALF. THE SNAP WAS REPORTED AS BEING A CLEAN BREAK. THERE WAS NO HARM TO THE PT AND IT DID NOT DELAY TREATMENT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247608 | SIL R ANG THORACIC 32FR | THORACIC CATHETER | KDQ | COVIDIEN | 8888573055 | 0270312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |