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	07/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a piece of the feeding pump connector's tip broke off some time during a four (4) hour feeding.The break was not identified until the feeding was completed and the feeding pump set was disconnected from the patient's gastrostomy tube (g-tube).When the broken connector tip was identified, a syringe was reportedly attached to the g-tube and the piece was successfully aspirated out of the patient.No further incident occurred.No adverse patient impact or follow-up care was reported.No sample has been returned for evaluation.A root cause for the reported incident could not be determined at this time.Due to the reported need for medical intervention to retrieve the piece of the connector tip, 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 feeding pump connector's tip broke off.
Additional Manufacturer Narrative
A sample was received by the manufacturer with evaluation completed on 16-aug-2021.The sample was received in a manila envelope with no other packaging.Upon inspection, the item appeared to be in the advised condition with a u-shaped piece of plastic missing from the upper most tier of the product.The reported connector problem/issue was confirmed, however, attempts to re-create the problem/issue were unsuccessful and root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• 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: 12269663
• Report Number: 1417592-2021-00121
• Device Sequence Number: 11446456
• 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,Followup
• Report Date (Section B): 09/03/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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: Required Intervention