MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; EP MAJOR PACK

Catalog Number	DYNJT4722
Medical Device Problem Codes	Break (1069); Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "components are broken or mishaped within the packs, the packs show no signs of damage on the shelf or when being opened.Components with shown to have defects: bd 10 ml syringe (found in 2 seperate packs) pitcher (found 3 seperate packs) basin.".
Additional Manufacturer Narrative
The complaint reported ¿components are broken or mishaped within the packs, the packs show no signs of damage on the shelf or when being opened¿ and identified defects with ¿bd 10 ml syringe (found in 2 seperate packs) pitcher (found 3 seperate packs) basin¿; clarification stated ¿during set up bent emesis basin,¿ ¿during surgery syringe broke,¿ ¿during set up, syringe was broken and damaged pitcher,¿ and ¿cracked pitcher,¿ with ¿did an injury occur? :no.¿ we received three photos and no physical sample was available; finished good production records and finished good pack build were reviewed, with no line down situations, no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, and the component placements did not contribute to the reported damage.Upon reviewing the photographs, the emesis basin was slightly bent on the exterior surface, confirming the reported issue; the cracked pitcher defect was unable to be confirmed, as no physical sample or detailed photographic evidence was provided to support the investigation.For the bent emesis, the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the pack; the division will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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: EP MAJOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854184
• Report Number: 1417592-2026-47468
• Device Sequence Number: 18515917
• Product Code: OEZ
• UDI-Device Identifier: 10198459454820
• UDI-Public: 10198459454820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/17/2026

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: DYNJT4722
• Device Lot Number: 25IMB293
• Was Device Available for Evaluation?: No
• 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: 12/18/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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