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

Model Number	60EY
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
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 nurse clamped port appropriately.Milk noted to be coming out of the area where tubing meets ¿christmas tree¿ part of tubing.They inspected tubing and found a small leak in extension tubing set.Continuous feed had to be stopped and extension set had to be replaced.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meet all quality standard requirements.A sample was received for the evaluation.After inspecting the sample, no leakage was noticed.Therefore, the reported condition could not be confirmed.It was not possible to determine the definite root cause of the reported condition.In the manufacturing process 100% leakage test is performed on cap, step connector and dust cover assembly.A sampling plan change is made at a rigorous level to contain possible leaks and occlusion test in extension kits in the manufactured lots.

• 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: 8676723
• Report Number: 9612030-2019-02195
• Device Sequence Number: 11518353
• Product Code: KNT
• UDI-Device Identifier: 20884521143934
• UDI-Public: 20884521143934
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/18/2019

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: 1905722664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1