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

Catalog Number	60131554
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "attached the syringe to the manifold and reported that the syringe unwinded iteself immediately completely loose".Due to this, a new device was obtained.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 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
Syringe would not stay attached to the manifold.
Additional Manufacturer Narrative
Updates to b3, d3, e1, and h6.After further investigation, the date of event has been confirmed as 4/19/24, and the telephone and fax numbers of the initial reporter were added.The manufacturer name and address has been corrected.The investigation included testing of the actual/suspected device, a review of production records, and a trend analysis.Testing demonstrated a mechanical issue in which the syringe and manifold were connected and disconnected three times, and in all three attempts the syringes backed off or rolled free from the manifold connection, thereby replicating the reported defect.The root cause was identified as a manufacturing deficiency: excess silicone originating from the rotating adapter (ra) swage machine during the ra swage process due to insufficient cleaning frequency of the swage stations.This excess silicone accumulated and migrated onto the syringe barrels, and subsequently onto the syringe luers as the product progressed through later manufacturing steps (binning, transport, assembly machine loading, conveyor movement, and vibratory bowl feeding).The combination of excess silicone on the luer and the presence of saline in the syringe reduced the luer-lock friction fit enough to allow the syringe/manifold connection to disconnect during use.If any additional relevant information is identified, a supplemental medwatch will be submitted.

• Common Device Name: MTS,LEFT HEART,KIT-MERITER HOSP -,PG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19333551
• Report Number: 3015910259-2024-00009
• Device Sequence Number: 3101994
• Product Code: OEZ
• UDI-Device Identifier: 20193489046936
• UDI-Public: 20193489046936
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/22/2026

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: 60131554
• Device Lot Number: 0000106071
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 01/23/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown