MAUDE Adverse Event Report: MEDLINE - NAMIC; LHK,-,CARLE,FOUNDATION HOSPITAL

Catalog Number	601006269
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "threads on control syringe were damaged on one and the syringe backed itself off of the manifold after being fully threaded on".There was no further information.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to the customer, "threads on control syringe were damaged on one and the syringe backed itself off of the manifold after being fully threaded on".
Additional Manufacturer Narrative
Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).

• Common Device Name: LHK,-,CARLE,FOUNDATION HOSPITAL
• Manufacturer (Section D): MEDLINE - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093-2753 ; 2173279112
• MDR Report Key: 19701904
• Report Number: 3015910259-2024-00020
• Device Sequence Number: 7991531
• Product Code: OEZ
• UDI-Device Identifier: 20193489189589
• UDI-Public: 20193489189589
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 601006269
• Device Lot Number: 23KBW790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Patient Sex: Unknown