MAUDE Adverse Event Report: MEDLINE MEDLINE ACCUTOUCH SYNTHETIC EXAM GLOVES

Model Number REF MDS192075

Device Problems Device Contamination with Body Fluid (2317); Torn Material (3024)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/07/2016

Event Type  malfunction  

Event Description

Employee was potentially exposed to patient blood; she noticed blood on her finger despite using gloves.When she removed the glove, she filled it with water and noticed that water freely flowed from the fingers of the effected glove.She repeated this procedure using other gloves and the same phenomenon occurred.

• Brand Name: MEDLINE ACCUTOUCH SYNTHETIC EXAM GLOVES
• Type of Device: ACCUTOUCH SYNTHETIC EXAM GLOVES
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 5719863
• MDR Text Key: 47216322
• Report Number: MW5062768
• Device Sequence Number: 1
• Product Code: LYZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: REF MDS192075
• Device Lot Number: RB608284263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other