MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TUBE,GASTROSTOMY,18FR,3-PORT,ENFIT

Catalog Number	ENFIT70318
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
"it was inserted into a patient and the balloon deflated".
Additional Manufacturer Narrative
It was reported by the customer contact that on (b)(3) 2023, "upon discharge, the nurse noticed that the tube was no longer in place".It was reported that due to this, an additional surgical procedure is required.It was reported that the patient was discharged and doing "fine".A sample was requested to be returned for evaluation.It has been determined that the reported event required medical intervention therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: TUBE,GASTROSTOMY,18FR,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: 18217479
• Report Number: 1417592-2023-00468
• Device Sequence Number: 14880278
• Product Code: PIF
• UDI-Device Identifier: 10888277411050
• UDI-Public: 10888277411050
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ENFIT70318
• Device Lot Number: 1104303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown