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

Model Number	60ES
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
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.
Event or Problem Description
The customer reported after priming, the feeding tube was leaking between the tubing and the connector.There was no harm to the patient.
Additional Manufacturer Narrative
A sample without the original package or lot number was received for evaluation.After performing a functional inspection, the condition reported was confirmed was observed; leaking was observed into the extension set.A review of the device history record (dhr) could not be conducted because a lot number was not provided.The most likely root cause for the leakage could be attributed to a workmanship issue.The manufacturing process was reviewed and during the assembly process it could have lacked solvent during the bonding process generated by dispenser when the application is performed without the guide pin.During the manufacturing process a 100% leakage test is performed on cap and step connector and dust cover assembly, at present the quality inspection in the occlusion and leakage tests is sampled at a reduced level, a sampling plan change is made at a more rigorous level to contain possible leaks and occlusion in the extension kits.

• Brand Name: MICROBORE EXTENSION SET 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: 8625239
• Report Number: 9612030-2019-02183
• Device Sequence Number: 2293187
• Product Code: KNT
• UDI-Device Identifier: 20884521143910
• UDI-Public: 20884521143910
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 60ES
• Device Catalogue Number: 60ES
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1