MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-PALL FILTER TURNOVER KIT-LF

Catalog Number	DYNJAA0355B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to while checking the patient's iv, it was noted that the iv tubing was leaking at two sites.It was between the connection point between the microbore tubing and the pall filter.6fr feeding tube was replaced due to leakage at the connection site.There was no further information.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.
Event or Problem Description
According to while checking the patient's iv, it was noted that the iv tubing was leaking at two sites.It was between the connection point between the microbore tubing and the pall filter.

• Common Device Name: DBD-PALL FILTER TURNOVER KIT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21118745
• Report Number: 1417592-2025-00017
• Device Sequence Number: 7436948
• Product Code: CAI
• UDI-Device Identifier: 40195327331949
• UDI-Public: 40195327331949
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/09/2025

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
• Device Catalogue Number: DYNJAA0355B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 01/09/2025
• 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
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 27 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White