MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; POUCH,STERILIZATION,SELF-SEAL,5 X15

Catalog Number	MPP100550GSZ
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have these peel packs that are not changing color when sterilized.".
Additional Manufacturer Narrative
The customer reported the pouch, sterilization was not changing color.Medline quality received 1 ea of the item for evaluation, and the color of the steam indicator did change from light pink to brown.The reported problem was not confirmed; after investigation, the complaint was determined to be a customer knowledge issue because the gas/eo indicator only changes color when it is run through an eo cycle.A retrospective review of the past year indicated that there have been no prior complaints in regard to this issue, 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: POUCH,STERILIZATION,SELF-SEAL,5 X15
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945844
• Report Number: 1417592-2026-54146
• Device Sequence Number: 18529859
• Product Code: KCT
• UDI-Device Identifier: 30080196323436
• UDI-Public: 30080196323436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243431
• 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): 09/29/2026

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: MPP100550GSZ
• Device Lot Number: (10)02722050001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2023
• 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: 02/06/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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