MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SYRINGE,EAR/ULCER, 2 OZ, STERILE

Catalog Number	DYND70280
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one that is sealed appears to have little bugs on the inside of the sealed packaging.
Additional Manufacturer Narrative
The customer said that she received two from the hospital she recently stayed at and that they are both individually sealed; one that is sealed appears to have little bugs on the inside of the sealed packaging.Without a sample received it is difficult to determine a true root cause; since no lot was given at the time of the report, no additional manufacturing/dhr review can be performed, and a retrospective review of the past 6 months preceding the reported issue revealed no additional complaints of particulates in packaging.The issue could not be confirmed; no samples were received.Root cause was not determined, with cause code description "sample required to determine cause," and the division is to monitor during quarterly trending; if a sample, photo, and/or additional information becomes available, the complaint will be reopened to be further investigated.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: SYRINGE,EAR/ULCER, 2 OZ, STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945670
• Report Number: 1417592-2026-54116
• Device Sequence Number: 15827488
• Product Code: KYZ
• UDI-Device Identifier: 40080196035039
• UDI-Public: 40080196035039
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/28/2026

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: DYND70280
• 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: 06/01/2023
• Initial Report FDA Received Date: 09/30/2026
• 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