MAUDE Adverse Event Report: COVIDIEN GSTRO FEED TBE W/Y PRT 14FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715148
Medical Device Problem Codes	Obstruction of Flow (2423); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
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 reports clogged feeding tubes and tubes splitting.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR
• 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: 8789946
• Report Number: 9612030-2019-02216
• Device Sequence Number: 14033707
• Product Code: KNT
• UDI-Device Identifier: 10884521007222
• UDI-Public: 10884521007222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/15/2019

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: 8884715148
• Device Catalogue Number: 8884715148
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1