MAUDE Adverse Event Report: NAMIC - MEDLINE INDUSTRIES; MTS,LEFT HEART,KIT-MORTON,PLANT HOSP PG

Catalog Number	60131679
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe connection issue.
Additional Manufacturer Narrative
It was reported that there was " issue is the control syringe is unraveling and not connecting properly posing the threat of air into the system".No additional information has been provided.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 (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.

• Common Device Name: MTS,LEFT HEART,KIT-MORTON,PLANT HOSP PG
• Manufacturer (Section D): NAMIC - MEDLINE INDUSTRIES; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22898853
• Report Number: 3015910259-2025-00062
• Device Sequence Number: 15699506
• Product Code: OEZ
• UDI-Device Identifier: 10193489047004
• UDI-Public: 10193489047004
• 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
• Report Date (Section B): 08/26/2025

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
• Device Catalogue Number: 60131679
• Device Lot Number: 25CBM672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown