MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES; SET,PUMP,1000ML BAG,ENFIT,MEDLINE

Model Number	ENFIT70552
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a piece of the tip of the enfit pump set connector was found to have broken off.This break was found at the completion of a one (1) hour feeding when the pump set was being disconnected from the patient's gastrostomy tube (g-tube).When the break was identified, a syringe was reportedly attached to the patient's g-tube in an attempt to aspirate and retrieve the broken piece.Aspiration was unsuccessful and the broken piece was unable to be retrieved.Since the date of incident, no adverse impact to the patient has been noted and the patient has required no additional medical intervention.The device involved in the incident was no longer available to be returned for evaluation.A root cause could not be determined at this time.Due to the reported need incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a piece of the tip of the enfit pump set connector was found to have broken off.

• Brand Name: MEDLINE INDUSTRIES
• Common Device Name: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12238795
• Report Number: 1417592-2021-00126
• Device Sequence Number: 17061686
• Product Code: KNT
• UDI-Device Identifier: 10884389190333
• UDI-Public: 10884389190333
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: ENFIT70552
• Device Catalogue Number: ENFIT70552
• Device Lot Number: 96920120002
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/28/2021
• 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: Other; Required Intervention