MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. GASTROSTOMY TUBE WITH ENFIT CONNECTOR; TUBE,GASTROSTOMY, 20FR, 3-PORT, ENFIT

Model Number ENFIT70320

Device Problems Burst Container or Vessel (1074); Physical Resistance/Sticking (4012)

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

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by (b)(6) that several patients (5-in total) had either experienced the "balloon burst or the g-tube get sucked to the intestine" while using the enfit 3-port gastrostomy 20 fr tube.Reporter states that on (b)(6) 2020 "the balloon burst" of enfit 3-port gastrostomy 20 fr.Tube.Reporter does not state or give details as to how the enfit 3-port gastrostomy tube balloon burst.It was reported the patient is a (b)(6) female, weighing approximately (b)(6).Reporter states, the g-tube was removed that same day and a new g-tube placed by a registered nurse.Reporter states the same product make and model (enfit 3-port gastrostomy 20 fr tube) used for replacement.Reporter states, "g-tube site redness noted," no serious injury reported.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Sample is not available for return and evaluation.Due to the reported medical intervention, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that several patients (5-in total) had either experienced the "balloon burst or the g-tube get sucked to the intestine" while using the enfit 3-port gastrostomy 20 fr tube.

• Brand Name: GASTROSTOMY TUBE WITH ENFIT CONNECTOR
• Type of Device: TUBE,GASTROSTOMY, 20FR, 3-PORT, ENFIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10822937
• MDR Text Key: 221288487
• Report Number: 1417592-2020-00125
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10888277411067
• UDI-Public: 10888277411067
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENFIT70320
• Device Catalogue Number: ENFIT70320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 51