MAUDE Adverse Event Report: MEDLINE, LP; MTO,-,LEFT HEART,KIT

Catalog Number	60193091
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024, "the syringe was connected to the back end of the manifold while flushing the manifold it started to unscrew or back itself off".The facility stated this was for a left heart cath procedure and the issue was discovered prior to use.The facility stated there was no patient involvement, no serious injury, and that there was no impact to the patient.The procedure was completed without the affected syringe.A sample is available for evaluation.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.
Event or Problem Description
According to the facility on 11/11, "the syringe was connected to the back end of the manifold while flushing the manifold it started to unscrew or back itself off".
Additional Manufacturer Narrative
Corrected d9: received date updated h3, updated h6 b, updated h6 c, updated h6 d.

• Common Device Name: MTO,-,LEFT HEART,KIT
• Manufacturer (Section D): MEDLINE, LP; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20860851
• Report Number: 3015910259-2024-00044
• Device Sequence Number: 3918451
• Product Code: OEZ
• UDI-Device Identifier: 20193489050988
• UDI-Public: 20193489050988
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/11/2026

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
• Device Catalogue Number: 60193091
• Device Lot Number: 0000132842
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/11/2026
• 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
• Patient Sex: Unknown