MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; POUCH TYVK 3.5" X 9" SELF SEAL

Catalog Number	MPP100650NZ
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pouches melted and failed the spore check for autoclave.
Additional Manufacturer Narrative
The customer advised pouches melted and failed the spore check for autoclave.Medline quality received 1 bx of the item for evaluation, and visual inspection was conducted with the provided sample; no abnormalities have been found.The complaint was determined to be a customer knowledge, as the customer is using the wrong sterilization pouch: they are currently using a tyvek pouch which is intended for low temperature sterilization, and they should be using a paper sterilization pouch which is intended for steam sterilization.The division will continue to monitor this issue for trending, and no credits or replacements will be issued at this time.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 TYVK 3.5" X 9" SELF SEAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805572
• Report Number: 1417592-2026-43866
• Device Sequence Number: 16095925
• Product Code: FRG
• UDI-Device Identifier: 30080196752649
• UDI-Public: 30080196752649
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153540
• 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): 09/17/2026

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: MPP100650NZ
• Device Lot Number: 88323040001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2024
• 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: 03/13/2024
• Initial Report FDA Received Date: 09/17/2026
• 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