MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number 31140257

Device Problems Break (1069); Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/30/2015.An investigation is currently underway.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 a lite glove.The customer states that the lite glove is tighter and therefore difficult to put on the lite handle.The installed settings of the or lite was also changed because of the tighter light glove.The upper site (the circle) seems weaker and therefore folds inside, so the lite glove becomes unsterile.The customer further reports that there is a big tear in the lite glove, that happened when putting the lite glove on the handle.

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed, no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two samples decontaminated with lot number 5181104464x were received for evaluation.The samples were visually inspected according to procedure; one sample presented stress marks, without a split in the wall of the handle section.The other sample presented a split in the handle section of the small rib.The reported condition by the customer was confirmed.The lite gloves are thermoformed and are manufactured by our supplier using green film.The lite gloves are packaged in singles, doubles or in kits and they can be sold sterile or non-sterile in bulk.In the thermoforming process, during its natural process, the film is heated, conveyed through the machine to reach the mold and after molding it will be cut into individual pieces; the molded part is obtained from a thermal shock generated vacuum pressure, positive pressure and cooling.The root cause identified was in the forming process as the forming tool has a high temperature.The reason is due to properties of the delring material, it keeps the heat concentrated at the point of contact with the film and does not dissipate to the rest of the tooling to stay balanced.This may cause the film to overheat and could potentially affect the strength of the material.A corrective/preventative action (capa) was initiated to address this issue.As a result, the plug assists were changed.An engineering test request (etr) was performed to determine the better temperatures for forming.After the etr was approved, validation was performed to confirm the proposed parameters and ensure the quality of the product.The hytac plug assists was validated and approved on jul 31, 2015 , with this new process it was possible to lower oven temperatures about 20 degrees c by zone.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
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5191621
• MDR Text Key: 30349099
• Report Number: 9612030-2015-00105
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• 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: 5181104464X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1