FDA Adverse Event
Injury
Summary report: N
STR THOR CATH 24FR
MDR report key: 2170713
·
Received July 12, 2011
Report
- Report Number
- 9611018-2011-00004
- Event Type
- Injury
- Date Received
- July 12, 2011
- Date of Event
- June 14, 2011
- Report Date
- June 14, 2011
- Manufacturer
- COVIDIEN
- Product Code
- KDQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 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 THORACIC CATHETER. THE CUSTOMER STATES THAT DURING DRAINAGE ON THE PT, THE HOLES IN THE PROXIMAL AREA OF THE CATHETER WERE MISSING. THE CUSTOMER REPORTS THAT THE PT RECEIVED A TAMPONADE AS THE BLOOD COULD NOT DRAIN OFF AND WAS SAVED WITH AN EMERGENCY SURGERY. THE CUSTOMER WILL NOT PROVIDE ANY FURTHER INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STR THOR CATH 24FR | THORACIC CATHETER | KDQ | COVIDIEN | 8888570531 | 10L660E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |