FDA Adverse Event
Injury
Summary report: N
THAL-QUICK ABSCESS DRAINING SET
MDR report key: 3131409
·
Received May 8, 2013
Report
- Report Number
- 1820334-2013-00209
- Event Type
- Injury
- Date Received
- May 8, 2013
- Date of Event
- April 13, 2013
- Report Date
- April 19, 2013
- Manufacturer
- COOK, INC.
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
ON (B)(6) 2013, THE PT WAS "ADJUSTING HIS POSITION IN BED" AND THE FLARED END OF THE 24FR THAT-QUICK ABSCESS DRAINAGE SET BROKE OFF. THE INTERVENTIONAL RADIOLOGY STAFF WAS CALLED IN AND REPLACED/EXCHANGED THE REMAINING CATHETER OVER A WIRE. ON (B)(6) 2013, INTERVENTIONAL RADIOLOGY WAS CALLED BY NURSING STAFF AND INFORMED THAT THE DRAINAGE CATHETER HAD "BROKEN" AGAIN. THE PT WAS TRANSPORTED TO RADIOLOGY AND THE REMAINING PORTION OF THE DRAINAGE CATHETER WAS EXCHANGED AND REPLACED. (1820334-2013-00210) ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202502 | THAL-QUICK ABSCESS DRAINING SET | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | COOK, INC. | NA | 4031050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |