MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC MEDLINE; MTO,SAMMC,KIT,SAN ANTONIO,MILITARY MED

Catalog Number	650204216
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that technicians have reported that the syringe is unraveling from the attached manifold port and that the syringe is very wobbly when attached to the manifold.
Additional Manufacturer Narrative
It was reported that "technicians have reported that the syringe is unraveling from the attached manifold port" and that "the syringe is very wobbly when attached to the manifold." per the customer "this has been seen three times in the last week." there was no contact information provided in the report that medline received from the medwatch (mw5184156) to follow up with the customer therefore no additional information is available to be obtained.The customer referenced medwatch report mw5184157 in the description of the event.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 1417592 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.
Additional Manufacturer Narrative
Update to h6, h7, and h9.After further investigation, it has been determined that the investigation involved an analysis of production records, and the device was not returned for evaluation.A manufacturing process problem was identified, and the root cause was attributed to a manufacturing deficiency related to recall r-26-025-fgx1.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: MTO,SAMMC,KIT,SAN ANTONIO,MILITARY MED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24692006
• Report Number: 3015910259-2026-00100
• Device Sequence Number: 15895485
• Product Code: OEZ
• UDI-Device Identifier: 10193489074901
• UDI-Public: 10193489074901
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 650204216
• Device Lot Number: 0000177238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-025-FGX1
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown