MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; APPLICATOR,COTTON-TIP,WOOD,3,STRL

Catalog Number	MDS202105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 3 malfunction events that occurred between july 1 and september 30, 2025.The account reported that wooden applicator sticks (mds202105) were splintering within the package prior to use.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 3 malfunction events that medline became aware of during july 1, 2025, through september 30, 2025.Associated lot numbers 29524110006, 29524060008, and 29525040007.The quantity associated with the reported issue was 6 bx.A complaint was received regarding mds202105 following reports that wooden applicator sticks were splintering within the package prior to use.Physical samples associated with lot numbers 29524110006, 29524060008, and 29525040007 were returned for evaluation.Medline quality received 6 bx in total, consisting of 4 bx from lot 29525040007 and 1 bx each from lots 29524110006 and 29524060008.Visual inspection identified no abnormalities with the packaging or product.All boxes were sealed and unopened at the time of receipt.Fifteen sticks were examined from each box, totaling 90 ea evaluated.No splintered sticks were identified during inspection.Additionally, the sticks did not break easily when removed from the packaging and required a reasonable amount of force to fracture.Based on the investigation, the reported issue could not be confirmed, and no evidence was identified indicating that the product failed to meet specifications.Complaint trending conducted over the previous two years identified only one similar complaint, which was also unconfirmed and associated with an unknown lot.No capa, scar, or additional risk management activities were deemed necessary based on the available information.The complaint will continue to be monitored through routine trend analysis.6 bx were returned for evaluation.The devices were labeled for single use.No devices were identified as reprocessed or reused.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: APPLICATOR,COTTON-TIP,WOOD,3,STRL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945909
• Report Number: 1417592-2026-54156
• Device Sequence Number: 9534632
• Product Code: KGX
• UDI-Device Identifier: 10080196306466
• UDI-Public: 10080196306466
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• 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: MDS202105
• 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: 07/23/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown