MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number 31140257

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/14/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer reports the light gloves are splitting.The customer is receiving 8-10 a day all from this same lot number that are splitting.The customer further reports no patient involvement and no medical intervention required.

Manufacturer Narrative

Additional information was provided by the customer.Lot#: originally reported as 6189100164 and should be 6169100164.

Event Description

The customer further reports that the lite glove was not too tight when placing on the handle.The split was found when placing on the handle during setup.This occurred when the patient was in the room.A new glove was placed once the tear was seen and the scrub tech changed gloves.A stryker handle was being used with the lite glove.The patient was not given any additional antibiotics as a result.

• Brand Name: 3612 LITE GLOVE
• Type of Device: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5948932
• MDR Text Key: 55050353
• Report Number: 9612030-2016-00430
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31140257
• Device Catalogue Number: 31140257
• Device Lot Number: 6169100164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1