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

Model Number	60ES
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/14/2020
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 that the tubing was melted and welded shut.It did not allow any flow through the tube.There was no patient injury.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information provided by the customer stating that the issue was discovered upon opening the package and that there was no patient involvement.Section h6 updated: patient code has been updated to 2645 no patient involvement.
Event or Problem Description
The customer reported that the tubing was melted and welded shut.It was not allowing any flow through the tube.Additional information provided by the customer stated that the issue was discovered upon opening the package.There was no patient involvement.

• 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: 9977440
• Report Number: 9612030-2020-02454
• Device Sequence Number: 13995297
• Product Code: KNT
• UDI-Device Identifier: 20884521143910
• UDI-Public: 20884521143910
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/22/2020

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
• Device Lot Number: 1928814864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1