MAUDE Adverse Event Report: COVIDIEN 3611 LITE GLOVE

Model Number 31140208

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/13/2016.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 states that the product is breaking.

Manufacturer Narrative

Submit date: 10/19/2016.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One case of samples with original packaging was received and the reported issue was not confirmed; none of the samples presents the reported condition.A corrective and preventative action (capa) has been opened to determine the root cause of this reported event.When root cause(s) is determined the appropriate actions will be taken to address the reported condition.If additional information is received this complaint will be reopened.This complaint will be used for tracking and trending purposes.

• Brand Name: 3611 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 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5720056
• MDR Text Key: 47237683
• Report Number: 9612030-2016-00284
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31140208
• Device Catalogue Number: 31140208
• Device Lot Number: 5132100764X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1