MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PRX MINOR PACK

Catalog Number	DYNJ81781
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the pack was not sealed" and "it slid right out of the pack onto the floor.".
Additional Manufacturer Narrative
The customer reported that one of the girls from the operating room pulled this pack from the case and the pack was not sealed; per rep: the white tyvek seal.A photo was received for the investigation, and the photo shows one unopen pack sitting outside and on top of the breather pouch; finished good production records and finished good pack build were reviewed, and there were no issues that might have had an impact on this issue.With the photo provided, medline was unable to confirm the issue and determine the root cause.The complaint was provided to the vendor for further evaluation, and the supplier quality team will also 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: PRX MINOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50752793
• Report Number: 1417592-2026-39001
• Device Sequence Number: 18481987
• Product Code: FDE
• UDI-Device Identifier: 40195327142897
• UDI-Public: 40195327142897
• 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): 09/09/2026

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: DYNJ81781
• Device Lot Number: 24CBS578
• Was Device Available for Evaluation?: Yes
• 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: 09/17/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown