MAUDE Adverse Event Report: COVIDIEN EXTENSION SET 60IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	60ENS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reported they went to use the extension tube and could not push air thru the tube, the tube was blocked.There was no patient harm.
Additional Manufacturer Narrative
The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The product was manufactured on july 15, 2020.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated sample without the original package or lot number was received at the manufacturing site for evaluation.Upon a visual and functional evaluation, the reported issue was confirmed.The multidisciplinary team performed a gemba walk into the manufacturing process.All process and controls were found properly followed including sub-assemblies, and inspections performed to the product.There were no abnormal conditions observed that could trigger the reported condition.The most likely root cause was determined to be that there was an excessive application of solvent in the tube during the manufacturing process.Current controls in the manufacturing process include occlusion testing conducted by production personnel, this test is performed to 100% of parts in order to verify that no occlusions are present within the tube.Qa also performs occlusion testing utilizing an acceptable quality limit for material release.In addition, as a preventive measure, the following actions have been taken to avoid further reoccurrences: the quality sampling plan was increased from reduced to rigorous in order to strengthen the verification of material conformity and a notification was sent to personnel to heighten awareness of this condition.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: EXTENSION SET 60IN W ENFIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10727814
• Report Number: 9612030-2020-02673
• Device Sequence Number: 19669444
• Product Code: PIF
• UDI-Device Identifier: 10884521212084
• UDI-Public: 10884521212084
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/25/2021

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: 60ENS
• Device Catalogue Number: 60ENS
• Device Lot Number: 2018923864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1