MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MTO,SNGH,3,V,MANIFOLD,OFF,KIT,W/SQZ

Catalog Number	651407920
Medical Device Problem Codes	Decoupling (1145); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "while the kits were being flushed and prepped for the case, the syringe/manifold connection was not staying locked, and began leaking.The syringe was falling off of the manifold, and would not stay engaged.".
Additional Manufacturer Narrative
The customer reported that while the kits were being flushed and prepped for the case, the syringe/manifold connection was not staying locked and began leaking, and the syringe was falling off the manifold and would not stay engaged.A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint, and the review confirms that the lots met all material, assembly, and performance specifications.There have been no previously reported complaints for the packaging lot and component lots for similar issues, and a review of the trending report confirmed there have been no adverse trends for the complaint rate associated with product issue.The customer's reported complaint description cannot be confirmed, no sample was returned for evaluation; without receiving the product for evaluation, medline was unable to definitively determine a root cause, and no corrective action was taken 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: DBD-MTO,SNGH,3,V,MANIFOLD,OFF,KIT,W/SQZ
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50900642
• Report Number: 1417592-2026-51283
• Device Sequence Number: 18819340
• Product Code: OEZ
• UDI-Device Identifier: 10193489076134
• UDI-Public: 10193489076134
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/24/2026

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: 651407920
• Device Lot Number: 0000083559
• Was Device Available for Evaluation?: Yes
• 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: 10/11/2023
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown