FDA Adverse Event
Injury
Summary report: N
REDO DOUBLE LUMEN TPN CATHETER SET
MDR report key: 4071235
·
Received September 2, 2014
Report
- Report Number
- 1820334-2014-00402
- Event Type
- Injury
- Date Received
- September 2, 2014
- Date of Event
- August 4, 2014
- Report Date
- August 4, 2014
- Manufacturer
- COOK, INC
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
PER COMPLAINT FORM: "TPN-LINE BROKEN DISTAL OF THE Y-MANIFOLD. HOWEVER, TPN-LINE WAS ALREADY PLACED ON (B)(6) 2014 -- CUSTOMER THINKS BROKEN TPN-LINE DUE TO WRONG HANDLING. CUSTOMER TRIED TO REPAIR TPN-LINE WITH REPAIR-SET, BUT FAILED. A NEW TPN LINE WAS PLACED THE SAME DAY." REP HAS ADVISED THAT "THAT THIS COMPLAINT IS NOT RELATED TO BAD QUALITY OF THE PRODUCT. TPN-LINE WAS ALREADY PLACED ON (B)(6) 2014 AND CUSTOMER THINKS THAT RUPTURE WAS CAUSED DURING MANIPULATION OF TPN-LINE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. 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 |
|---|---|---|---|---|---|---|---|
| 532455 | REDO DOUBLE LUMEN TPN CATHETER SET | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | FOZ | COOK, INC | NA | 4548339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |