MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE 2X80

Model Number 31140257

Device Problems Fitting Problem (2183); Out-Of-Box Failure (2311); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with lite gloves.The customer reports the lite gloves are too tight to get it over lite handle.Some of the lite gloves are already torn when removed from the packaging.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process condition was present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Four decontaminated samples without original package or lot number were received.A sample analysis was performed; as part of the analysis the samples were visually inspected according to product specifications.The sample presented a split in the section of the small rib thereby confirming the reported issue.The root cause that was determined for this issue was a problem that occurred during the forming process in which the forming tool reaches a high temperature.Due to properties of the material, the heat is concentrated at the point of contact with the film and not dissipated throughout the rest of the tooling therefore it does not balance out.This may cause the film to overheat and could potentially affect the strength of the material.As a corrective action the material used for the plug assists was changed; the difference in this change is its properties, the heat stabilized around the tooling (not only the contact point with the film) having a lower impact on the film forming process.An engineering test request (etr) was performed to determine the best temperatures to form the lite glove with the new forming tool using the newer, improved material.After the etr was approved, validation was performing to confirm the proposed parameters and ensure the quality of the product.A formal corrective and preventative action was implemented as a result.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 3612 LITE GLOVE 2X80
• 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 22500 ; MX 22500
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5001820
• MDR Text Key: 24207209
• Report Number: 9612030-2015-00075
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• 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: 5153101464X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1