FDA Adverse Event
Injury
Summary report: N
PROMETRA INTRATHECAL CATHETER KIT
MDR report key: 7032488
·
Received November 15, 2017
Report
- Report Number
- 3010079947-2017-00158
- Event Type
- Injury
- Date Received
- November 15, 2017
- Date of Event
- October 18, 2017
- Report Date
- October 18, 2017
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- UDI-DI
- 00810335020099
- PMA / PMN Number
- P080012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A COMPANY REPRESENTATIVE REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE. A CATHETER REVISION WAS PERFORMED ON (B)(6) 2017. THE CATHETER WAS FOUND TO BE SLIGHTLY KINKED AND SEMI-DAMAGED. THE CATHETER WAS THEN REATTACHED TO THE PUMP AND IMPLANTED AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813037 | PROMETRA INTRATHECAL CATHETER KIT | IMPLANTABLE INTRATHECAL CATHETER KIT | LKK | FLOWONIX MEDICAL, INC | 11823 | 22449 | 00810335020099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |