FDA Adverse Event
Malfunction
Summary report: N
SAFETOUCH II
MDR report key: 1334864
·
Received October 21, 2008
Report
- Report Number
- 1056186-2008-00004
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- August 12, 2008
- Report Date
- September 22, 2008
- Manufacturer
- NIPRO MEDICAL CORPORATION
- Product Code
- FMI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NIPRO RENAL SPECIALIST SPOKE WITH INITIAL REPORTER ON 9/24/2008. SHE STATED THE ROOT CAUSE OF THE PROBLEM WAS RELATED TO THE USE OF ETHYL CHLORIDE SPRAY USED ON PATIENTS PRIOR TO CANNULATION. EVALUATION IS ONGOING AT MANUFACTURING FACILITY.
Description of Event or Problem · 1
ON 09/22/2008, NIPRO MEDICAL RECEIVED REPORT FROM FDA REGARDING AN INCIDENT WITH THE SAFETOUCH II SAFETY AVF NEEDLE. REPORT STATES THAT AFTER THE DIALYSIS TREATMENT WAS FINISHED, STAFF COULD NOT ACTIVATE SAFETY MECHANISM ON NEEDLE. NO INJURY TO PT OR STAFF WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFETOUCH II | SAFETY AVF NEEDLE | FMI | NIPRO MEDICAL CORPORATION | 15G X 1" HC-30W | 07F21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |