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

Model Number	DYNJ907373
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pvp bottle leaked.Pvp located inside subassembly.
Additional Manufacturer Narrative
The account reported finding pvp leaked, and the reported issue was for the kit pedi ear.A photo and a sample were received for the investigation; the sample was of just the betadine solution in a zip lock bag, no other pack contents were received, and there was no visible damage to the bottle nor the cap.The reported problem was confirmed because the bottle of betadine solution had leaked.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process; the complaint was provided to the vendor for further evaluation, no response was received after two follow ups, and supplier quality 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-KIT PEDI EAR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853403
• Report Number: 1417592-2026-47351
• Device Sequence Number: 21206697
• Product Code: LRO
• UDI-Device Identifier: 40193489887793
• UDI-Public: 40193489887793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Model Number: DYNJ907373
• Device Lot Number: 23FBB493
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2023
• 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: 08/03/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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