MAUDE Adverse Event Report: RNA MEDICAL / BIONOSTICS INC. RNA MEDICAL CVC223, CO-OXIMETER CALIBRATIN VERIFICATION

Model Number CVC223, LEVEL 5

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 10/03/2016

Event Type  Other  

Event Description

A poc coordinator at (b)(6), cut her finger while opening a glass ampoule of rna medical cvc 223, co-oximeter calibration verification control solution.

• Brand Name: RNA MEDICAL CVC223, CO-OXIMETER CALIBRATIN VERIFICATION
• Type of Device: OXIMETER
• Manufacturer (Section D): RNA MEDICAL / BIONOSTICS INC. ; MA
• MDR Report Key: 6039478
• MDR Text Key: 57973246
• Report Number: MW5065484
• Device Sequence Number: 1
• Product Code: JJY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: CVC223, LEVEL 5
• Device Catalogue Number: CVC2235
• Device Lot Number: 65228
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: UNK. ; RX MEDS: UNK.