MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC NAMIC; SC,3W,HP,RA,OFF,NB-,OEM

Catalog Number	80055009
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the syringe turns itself loose while injecting the contrast medium".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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.The customer was not able to confirm which of the following lot numbers were associated with the reported product issue: lot: 0000154130 and lot: 0000157733.The manufacturing dates for the potentially associated lot numbers are as follows: lot: 0000154130: 02/06/2025 and lot: 0000157733: 03/11/2025.
Event or Problem Description
It was reported that "the syringe turns itself loose while injecting the contrast medium".
Additional Manufacturer Narrative
Update to d4: lot number.Update to h4: manufacturing date.

• Brand Name: NAMIC
• Common Device Name: SC,3W,HP,RA,OFF,NB-,OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24782430
• Report Number: 3015910259-2026-00108
• Device Sequence Number: 6065839
• Product Code: DTL
• UDI-Device Identifier: 10193489066661
• UDI-Public: 10193489066661
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/29/2026

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: 80055009
• Device Lot Number: 0000157733
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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