MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TUBE, GASTRIC SUMP, 18FR, 48", 50/CS

Catalog Number	DYND72018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	04/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, there have been "various patients" where the gastric tube is leaking at the "connection point of tube and appliance to hook to suction/tube feeding".The customer reported after the issue occurs, they "wrap the connection with gauze and tape" to prevent leakage onto patients.The customer reported the patients do "not receive prescribed tube feed dose due to leakage".The customer reported there was no serious injury, medical intervention, or follow-up care required as a result of the reported incident.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
According to the customer, there have been "various patients" where the gastric tube is leaking at the "connection point of tube and appliance to hook to suction/tube feeding".
Additional Manufacturer Narrative
Update to h6: investigation conclusions.

• Common Device Name: TUBE, GASTRIC SUMP, 18FR, 48", 50/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19604681
• Report Number: 1417592-2024-00679
• Device Sequence Number: 15301825
• Product Code: KNT
• UDI-Device Identifier: 40080196036760
• UDI-Public: 40080196036760
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND72018
• Device Lot Number: 23JBL073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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