MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUSTOM PACK PROCEDURE PEARLMAN

Catalog Number	DYNJ63971A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an "open seal on breather pouch.".
Additional Manufacturer Narrative
The account reported finding open breather pouch seal.A photo and a sample were received for the investigation, and medline observed the edge of the breather pouch on the tyvek end was open, exposing the pack inside; the edge seal appears to have popped open, and there was also one hole in the side of the pouch that punctured the back table cover.The reported issue was confirmed.Medline receives this item pre-sealed from the component supplier, and the root cause was confirmed to be related to an error in the component manufacturing process; the complaint was provided to the vendor for further evaluation, and the supplier quality team will monitor this issue for trending purposes.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: CUSTOM PACK PROCEDURE PEARLMAN
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852367
• Report Number: 1417592-2026-47236
• Device Sequence Number: 13138696
• Product Code: LRO
• UDI-Device Identifier: 40193489289368
• UDI-Public: 40193489289368
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: DYNJ63971A
• Device Lot Number: 23CBG036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2023
• 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: 04/10/2023
• 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