MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LHK,,CHRISTUS, MED CTR/NB

Catalog Number	VASC1336
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 10 ml syringe we attach will back off the manifold which could lead to air embolism.It appears to be a defect in the manifold end where the syringe attaches.".
Additional Manufacturer Narrative
The customer reported that the 10 ml syringe they attach will back off the manifold, which could lead to air embolism, and that it appears to be a defect in the manifold end where the syringe attaches.A review of the device history records was performed for the indicated packaging and component lots for any deviations or nonconformance related to the reported defect of the complaint, and the review confirms that the lots met all material, assembly, and performance specifications; no product was returned for evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned for evaluation, and without receiving product for evaluation, medline was unable to definitively determine a root cause for this incident.Dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture, and based on no issues noted in the dhr and adequate process controls in place, 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: DBD-LHK,,CHRISTUS, MED CTR/NB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915844
• Report Number: 1417592-2026-52051
• Device Sequence Number: 12206650
• Product Code: OEZ
• UDI-Device Identifier: 40195327148561
• UDI-Public: 40195327148561
• 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: VASC1336
• Device Lot Number: 23JBQ166
• 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: 12/28/2023
• 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