MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE; GLOVES, SURGICAL

Lot Number 1906470304

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Nurse was putting on sterile gloves to access patient's port.When pulling on gloves the left cuff of the glove developed a hole.Gloves discarded and new gloves used.Nurse states she is doing nothing different when doning gloves and this happens frequently.Packaging, but gloves not saved.

• Brand Name: MEDICHOICE
• Type of Device: GLOVES, SURGICAL
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC; 2301 robb drive; reno NV 89523
• MDR Report Key: 9278552
• MDR Text Key: 165090024
• Report Number: 9278552
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1906470304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2190 DA