MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE POLYISOPRENE GLOVES

Model Number SGL95060

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Nurse was going to access the patient's port to give medication.When she went to put on the sterile gloves the left cuff broke off.Gloves discarded and new gloves applied.

• Brand Name: MEDICHOICE POLYISOPRENE GLOVES
• Type of Device: GLOVES
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC; 2301 robb drive; reno NV 89523
• MDR Report Key: 9171480
• MDR Text Key: 161695908
• Report Number: 9171480
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGL95060
• Device Catalogue Number: SGL95060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5840 DA