MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SPECIAL PROCEDURE CLOSED SYS

Catalog Number	000000000065131934
Medical Device Problem Codes	Decoupling (1145); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the connector on the namic flush kit is not staying connected and we are getting air bubbles in the syringes.".
Additional Manufacturer Narrative
The reported issue was that the connector on the namic flush kit is not staying connected and air bubbles were observed in the syringes.A review of the device history records was performed for the reported item and any deviations related to the reported defect; the review confirms that the lot met all material, assembly and performance specifications, and there have been no previously reported complaints for similar issue and no adverse trends.Product analysis was not performed because no product was returned for evaluation, and the customer's reported complaint description cannot be confirmed.Without receiving product for evaluation, medline was unable to definitively determine a root cause; no correction is required and no corrective action to be taken by medline at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: SPECIAL PROCEDURE CLOSED SYS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915139
• Report Number: 1417592-2026-51962
• Device Sequence Number: 5393559
• Product Code: OEZ
• UDI-Device Identifier: 10193489061765
• UDI-Public: 10193489061765
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 000000000065131934
• Device Lot Number: 22DBR486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown