MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PRIMARY KIT

Catalog Number	DYKE1568B
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "suction canister inside the pack is not maintaining suction when being used for procedure.".
Additional Manufacturer Narrative
The account reported finding defective suction canister, and the end user reported that the canister was not maintaining suction when being used for a procedure.Medline reviewed finished good production records, finished good pack build, account and component trending, and evaluated one unused canister sample; the canister was observed compressed and deflated, with no issues with the lid or plastic canister portion.Vendor response stated reserved samples were tested and the vacuum system of the product ran as normal, pressure meter read as normal, sealing was normal, water suction was functioning normally, and production records met the quality requirements with no deviations or rework.Since the defect is not confirmed, it is not possible to determine the root cause; supplier quality team will monitor this issue for trending purposes.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-PRIMARY KIT
• 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: 50855912
• Report Number: 1417592-2026-47794
• Device Sequence Number: 15841179
• Product Code: LRO
• UDI-Device Identifier: 40193489869126
• UDI-Public: 40193489869126
• 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): 09/21/2026

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: DYKE1568B
• Device Lot Number: 23BBP261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2023
• 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: 04/19/2023
• Initial Report FDA Received Date: 09/22/2026
• 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