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

Model Number 8884721088

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12324493
• MDR Text Key: 266651399
• Report Number: 9612030-2021-03026
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884721088
• Device Catalogue Number: 8884721088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Patient Sequence Number: 1