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

Catalog Number	ENFIT70552
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 04/08/24 there was an issue "at the connection site where it screws into extension tubing" causing the feeding to leak.Per the facility when this occurred the patient required additional tube feeding as they did not receive the full volume with the original feed administration.Per the facility they do not have any additional specific information about the incident(s) and are unable to confirm the number of events.The sample has been requested 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.Multiple lots listed: 96923110001, 9692311004, 96923120002.
Event or Problem Description
According to the facility on 04/08/24 there was an issue "at the connection site where it screws into extension tubing" causing the feeding to leak.

• Common Device Name: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19519754
• Report Number: 1417592-2024-00644
• Device Sequence Number: 15538149
• Product Code: PIF
• UDI-Device Identifier: 40884389190334
• UDI-Public: 40884389190334
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/12/2024

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: ENFIT70552
• Device Lot Number: MULTIPLE LISTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/12/2024
• 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 Age: 8 YR
• Patient Sex: Male
• Patient Weight: 21 KG