MAUDE Adverse Event Report: COVIDIEN MICROBORE EXT SET BIFUR 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	60EY
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports that the package was opened, and the tube was found to be cut through.
Additional Manufacturer Narrative
A sample with lot number: 1909223664 was received for evaluation.After performing a functional inspection, the condition reported was confirmed; the extension tube was cut in the sealed area.After reviewing our database and the device history record (dhr), the lot number reported by customer (b)(6) was provided incorrectly.Therefore, the dhr could not be reviewed.As a part of the investigation the multifunctional team performs a gemba walk to the production line where the product is packed.During the inspection, an issue was found with the equipment sensors that detect if a product is packaged incorrectly.It appears that the sensor did not detect the cut in the tube during packaging.An adjustment was made to the product sensor and the fiber optic was changed to detect incorrect collation of the product.

• Brand Name: MICROBORE EXT SET BIFUR 60IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8647399
• Report Number: 9612030-2019-02191
• Device Sequence Number: 1857832
• Product Code: KNT
• UDI-Device Identifier: 20884521143934
• UDI-Public: 20884521143934
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 60EY
• Device Catalogue Number: 60EY
• Device Lot Number: 1009113664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1