MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 5 FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461412
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
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 the feeding tube disconnected/broke between the tube and the hub.This was not noticed until the feed was found in the bed.The tube was intact for about twenty nine hours.This incident occurred in the nicu at the hospital.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.Two photographs were submitted for investigation and one decontaminated sample outside of its original package without a lot number was received for evaluation.After performing a visual inspection, the separation of the purple connector can be observed.A multifunctional team reviewed the complaint and reported condition; as a result, a formal investigation for corrective/preventative actions was initiated to address the ¿connector disassembly¿ condition.

• Brand Name: POLYUR FEED TUBE 5 FR X 20
• 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: 9202959
• Report Number: 9612030-2019-02324
• Device Sequence Number: 2951093
• Product Code: KNT
• UDI-Device Identifier: 10884521067967
• UDI-Public: 10884521067967
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: Health Professional
• Device Model Number: 461412
• Device Catalogue Number: 461412
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1