MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; DBD-MORSE,MAN,CL.3V,200/RH/OFF-PKG

Catalog Number	70039301
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, "when the hand injection syringe was screwed onto the luer lock connection on the transducer, the hand injection syringe would unwind itself from the transducer, connection point not secure.".
Additional Manufacturer Narrative
According to the facility, "when the hand injection syringe was screwed onto the luer lock connection on the transducer, the hand injection syringe would unwind itself from the transducer, connection point not secure." per the facility, the faulty device was detected before use on patient.Only a procedural delay reported due to need to set up a second set.No additional information at this time.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 e1: customer telephone number.

• Common Device Name: DBD-MORSE,MAN,CL.3V,200/RH/OFF-PKG
• 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: 23360767
• Report Number: 3015910259-2025-00094
• Device Sequence Number: 8797570
• Product Code: OEQ
• UDI-Device Identifier: 10193489065176
• UDI-Public: 10193489065176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2026
• Device Catalogue Number: 70039301
• Device Lot Number: 0000085362
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 83 KG