MAUDE Adverse Event Report: COVIDIEN ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient had a feeding tube (kao) inserted and it was advanced as ordered to 55cm.A few nurses tried to take out the sylet but could not remove it.There was no patient harm reported.
Additional Manufacturer Narrative
Section b5 has been updated to include: additional information provided by the customer on (b)(6) 2021 stated that the hydromer coating was activated with water prior to placement and was reactivated with water before attempting removal of the stylet.
Event or Problem Description
The customer reported that the patient had a feeding tube (kao) inserted and it was advanced as ordered to 55cm.A few nurses tried to take out the sylet but could not remove it.There was no patient harm reported.Additional information provided by the customer on (b)(6) 2021 stated that the hydromer coating was activated with water prior to placement and was reactivated with water before attempting removal of the stylet.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• 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: 12324493
• Report Number: 9612030-2021-03026
• Device Sequence Number: 2825992
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 8884721088
• Device Catalogue Number: 8884721088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1