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

Model Number	ENFIT70320
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by (b)(6) hospital 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 describes patient as a (b)(6)-year-old female, weighing approximately (b)(6) lbs., and states she incurred two incidents.The first incident ((b)(4)) occurring on (b)(6) 2020 reported as "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.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) was utilized as for replacement.Reporter states, "g-tube site redness noted," no serious injury reported.Second incident reported on (b)(6) 2020 ((b)(4)), patient's g-tube (enfit 3-port gastrostomy 20 fr tube) had "sucked into the intestine." 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.No additional details are available related to the customer reported issues.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(s) are not available for return and evaluation.Due to the reported medical intervention(s), this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem 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
• Common Device Name: TUBE,GASTROSTOMY, 20FR, 3-PORT, ENFIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10823741
• Report Number: 1417592-2020-00126
• Device Sequence Number: 17094568
• Product Code: PIF
• UDI-Device Identifier: 10888277411067
• UDI-Public: 10888277411067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: ENFIT70320
• Device Catalogue Number: ENFIT70320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 65