MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; MTS-LEFT HEART,KIT-NORTHWEST MED CENTER

Catalog Number	60141021
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the rotating adapter is very tight, and the customer has to turn it multiple times to ease the stiffness prior to attaching it to the manifold.The customer stated that otherwise, the syringe starts to loosen from the manifold and that sometimes the torque from the syringe attached to the manifold starts to loosen as well.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025, the rotating adapter is very tight, and the customer has to turn it multiple times to ease the stiffness prior to attaching it to the manifold.The customer stated that otherwise, the syringe starts to loosen from the manifold and that sometimes the torque from the syringe attached to the manifold starts to loosen as well.No additional details are available related to the customer reported issue.Despite 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 (b)(4) on (b)(6) 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
Correction to d3: manufacturer name, city, and state.Update to d9: device date returned to manufacturer.Update to h3: device evaluated by manufacturer.Update to h6: type of investigation (b), investigation findings (c).

• Common Device Name: MTS-LEFT HEART,KIT-NORTHWEST MED CENTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801 3864
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22394975
• Report Number: 3015910259-2025-00048
• Device Sequence Number: 9160858
• Product Code: OEZ
• UDI-Device Identifier: 10193489048162
• UDI-Public: 10193489048162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60141021
• Device Lot Number: 00001495558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown