FDA Adverse Event
Injury
Summary report: N
COOK TPN DOUBLE LUMEN TPN CATHETER
MDR report key: 3131016
·
Received May 9, 2013
Report
- Report Number
- 1820334-2013-00195
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 9, 2013
- Report Date
- April 18, 2013
- Manufacturer
- COOK INC
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNKNOWN AS LOT IS UNKNOWN. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A NURSE WAS FLUSHING LINE. THE LINE FLUSHED WITH NO RESISTANCE THEN BROKE ABOVE THE BIFURCATION. LINE WAS STABILIZED AND COVERED. THE LINE WAS REPAIRED ON THAT DAY USING A COOK 7 FRENCH REPAIR KIT. LINE WAS ABLE TO GIVE BLOOD RETURN IN THE YELLOW LUMEN AND FLUSHED WITH NO RESISTANCE POST REPAIR. THE BLUE LUMEN WAS ALTEPLASED 24 HOURS AFTER REPAIR AND GAVE EXCELLENT BLOOD RETURN AND FLUSHED WITH NO RESISTANCE. THE LINE THEN SHOWED A TEAR ABOVE THE REPAIR SITE (APPROX. 0.5 INCHES ABOVE THE REPAIR SITE). THE PATIENT HAD A NEW LIE INSERTED IN THE OPERATING ROOM INVOLVING ANESTHETIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205001 | COOK TPN DOUBLE LUMEN TPN CATHETER | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |