MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; LHK,-,CENTRAL,SUFFOLK HOSPITAL

Catalog Number	60033592A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 when prepping the manifold prior to a procedure the syringe "kept spinning" and "would not tighten completely" when attaching the syringe to the manifold.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2024 when prepping the manifold prior to a procedure the syringe "kept spinning" and "would not tighten completely" when attaching the syringe to the manifold.The customer reported there was no injury or impact to the patient.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 d9: device returned.Update to h3: device evaluated.Update to h6: type of investigation.Update to h6: investigation findings.

• Common Device Name: LHK,-,CENTRAL,SUFFOLK HOSPITAL
• 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: 20412011
• Report Number: 3015910259-2024-00041
• Device Sequence Number: 9044598
• Product Code: OEQ
• UDI-Device Identifier: 20197344000248
• UDI-Public: 20197344000248
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60033592A
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 03/12/2026
• 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