MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TUBE,GASTROSTOMY,16FR,3-PORT,ENFIT

Catalog Number ENFIT70316

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Tube slid out and required replacement.

Manufacturer Narrative

It was reported by the customer contact that on, " patient came in on (b)(6) to have a g-tube replaced.Patient came back on (b)(6) upset and reported the g-tube had slide out.A replacement was placed in real time".It was reported that the tube was replaced in "ir".There was no injury reported related to the incident.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: TUBE,GASTROSTOMY,16FR,3-PORT,ENFIT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17814040
• MDR Text Key: 324217289
• Report Number: 1417592-2023-00388
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10888277411043
• UDI-Public: 10888277411043
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ENFIT70316
• Device Lot Number: 1106108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other