inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Dec 5, 2016

Report 9612030-2016-00782 · MDR key 6146283

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

571711

Catalog number

571711

Product problems

  • Torn Material

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LITE HANDLE COVER IS COMING IN RIPPED ON HANDLE SIDE. THERE WAS NO INDICATION THAT THE GLOVE WAS TOO TIGHT ON THE HANDLE. ISSUE WAS FOUND DURING SETUP AND WAS REPLACED WITH NEW GLOVE. NO PATIENT INVOLVED.