MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SKN PREP SPNG STKS PVP PNT STR

Catalog Number	DYND70288S
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the sterile pouch was open so the kit isn¿t sterile.".
Additional Manufacturer Narrative
The reported issue was that the sterile pouch was open so the kit isn¿t sterile.Medline quality received 1 ea of item dynd70288s for evaluation, and visual inspection was conducted with the provided sample; it was found that the item is sealed all around properly, no holes have been found.At this time, the reported concern could not be confirmed, as the item was sealed properly.A retrospective review of the past year indicated that there have been one prior complaints in regard to this issue for item dynd70288s, and the division will continue to monitor this issue for trending.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: SKN PREP SPNG STKS PVP PNT STR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50853988
• Report Number: 1417592-2026-47425
• Device Sequence Number: 21313110
• Product Code: OJU
• UDI-Device Identifier: 40889942509851
• UDI-Public: 40889942509851
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: DYND70288S
• Device Lot Number: 23LBP722
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/22/2024
• 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: 02/14/2024
• 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