MAUDE Adverse Event Report: MEDLINE SENSICARE GREEN STERILE GLOVES; STERILE SURGICAL GLOVES

Lot Number 604833325675

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Event Description

Preparing for open heart case.Scrub tech started to put on sterile gloves and noticed something on one of the gloves.The something appears to be a winged insect.The gown table and all gowns and gloves were immediately removed from the room.None of these items came into contact with any other items that were opened in preparation for the surgery.The gloves are sensicare green.

• Brand Name: SENSICARE GREEN STERILE GLOVES
• Type of Device: STERILE SURGICAL GLOVES
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 6255890
• MDR Text Key: 65091419
• Report Number: MW5067235
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 20080196307729
• UDI-Public: (01)20080196307729
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2017

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 Expiration Date: 03/31/2019
• Device Lot Number: 604833325675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1