FDA Adverse Event
Malfunction
Summary report: N
INTROCAN SAFETY
MDR report key: 3952671
·
Received July 18, 2014
Report
- Report Number
- 2523676-2014-00277
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- May 12, 2014
- Report Date
- July 2, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS: NURSE HAD SUCCESSFUL ATTEMPT TO START IV. SAFETY CLIP DID DEPLOY. WHILE CLEANING UP, HAD A NEEDLE STICK. NO SAMPLE SAVED. MFR - 9610825-2014-00277.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423318 | INTROCAN SAFETY | I.V. SAFETY CATHETER | FOZ | B. BRAUN MELSUNGEN AG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |