MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MTS,L/H,KIT-JERSEY,SHORE MED

Catalog Number	000000000060100042
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we've had 3 instances today where the 12 cc syringe on the manifold kit continued to come off the manifold and allowed for air to get into the manifold.".
Additional Manufacturer Narrative
According to the customer, when prepping the manifold the syringe would "unscrew itself from the manifold" and the incident "can" introduce air into the system; the customer did not report patient involvement, and the issue was noted "before the case started." a review of the device history records was performed for the indicated packaging and component lots, and the returned samples were unopened; the suspect manifold and syringe were used in an attempt to replicate the same defect of the complaint.The connected samples were properly engaged and determined to pass, exhibiting no damage to either component, or the complaint is not confirmed.The root cause remains inconclusive at this time; no correction is needed at this time, no additional corrective actions to be taken by medline at this time, and medline will continue to monitor this anomaly for additional occurrences.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-MTS,L/H,KIT-JERSEY,SHORE MED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897201
• Report Number: 1417592-2026-50825
• Device Sequence Number: 5829402
• Product Code: OEZ
• UDI-Device Identifier: 20193489044901
• UDI-Public: 20193489044901
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 000000000060100042
• Device Lot Number: 0000084323
• 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: 07/25/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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