FDA Adverse Event
Other
Summary report: N
ON-Q C-BLOC
MDR report key: 1200216
·
Received October 1, 2008
Report
- Report Number
- 2026095-2008-00164
- Event Type
- Other
- Date Received
- October 1, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 5, 2008
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION CONCERNING THE PUMP LOT NUMBER. WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. IT WAS REPORTED THAT THE SAMPLE WAS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED. COMPLAINT IS UNDER INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BOLUS BUTTON WAS STUCK IN THE DOWN POSITION FOR AT LEAST 2 HOURS AND THE PATIENT WAS NOT GETTING ENOUGH PAIN RELIEF. IT WAS STATED THAT THE PATIENT DID NOT HAVE ANY SIGN OF TOXICITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q C-BLOC | INFUSION PUMP | MEB | I-FLOW CORP. | CB006 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |