MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MTS-4V,MANIFOLD,KIT-WEST. HILLS HOSP-PG

Catalog Number	60230373
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "the manifold syringe spins on its own and disengages".There was no further information.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available supplemental medwatch will be filed.
Event or Problem Description
According to the customer, "the manifold syringe spins on its own and disengages".
Additional Manufacturer Narrative
Update to g3: date received by manufacturer.

• Common Device Name: MTS-4V,MANIFOLD,KIT-WEST. HILLS HOSP-PG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19111733
• Report Number: 1417592-2024-00501
• Device Sequence Number: 17924192
• Product Code: OEZ
• UDI-Device Identifier: 20193489053040
• UDI-Public: 20193489053040
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/12/2026

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: 60230373
• Device Lot Number: 0000098701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 03/12/2026
• 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 Sex: Unknown