FDA Adverse Event
Malfunction
Summary report: N
SUBDURAL TUNNELING KIT
MDR report key: 537230
·
Received March 17, 2004
Report
- Report Number
- 2023988-2004-00027
- Event Type
- Malfunction
- Date Received
- March 17, 2004
- Report Date
- March 17, 2004
- Manufacturer
- INTEGRA NEUROCARE LLC
- Product Code
- HCA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE USER REPORTED DIFFICULTY IN PASSING CATHETERS THROUGH BOLT. BOLT AND CATHETERS WERE REMOVED AND REPLACED. THE SAME INCIDENT OCCURRED WITH THE REPLACEMENT KIT. THE TREATING PHYSICIAN WAS VERY FRUSTRATED. THE NURSING STAFF WAS NOT CONFIDENT IN THE ICP READINGS. THE DEVICE WAS DISCONTINUED TWO DAYS POST INSERTION. THE REPORTED LOT NUMBER B4765 IS A SUB-ASSEMBLY NUMBER. THIS PARTICULAR DEVICE LOT NUMBER IS S2150. TWO WERE USED BUT ONLY ONE WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBDURAL TUNNELING KIT | NEURO MONITORING | HCA | INTEGRA NEUROCARE LLC | * | S2150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |