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

Catalog Number	DYNJ51833A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Breather pouch not sealed.
Additional Manufacturer Narrative
The account reported finding breather pouch not sealed.A photo and a sample were received for investigation; the sample was of one pack with the pouch, and observations showed a single kit with track marks of the sealer indicating that it was passed through the sealer but was not correctly sealed; finished good production records, finished good pack build, trending, and a branch stock check were reviewed, with no line downs or non-conformance reported and branch stock check finding no defects.The reported problem was confirmed by the sample evaluation.After further review, there were no non-conformances or deviations in parameters or machine/process management as listed in the production paperwork that likely contributed to the error; the root cause of human/manual assembly error was determined because the employee responsible for ensuring the sealer was at proper parameters prior to sealing the first kit made a manual error of not verifying the proper temperatures were reached.Production and qc managers were notified, feedback would be provided to the build team for awareness and to prevent recurrence, and the issue will be monitored 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: PLASTIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947860
• Report Number: 1417592-2026-54506
• Device Sequence Number: 10348742
• Product Code: LRO
• UDI-Device Identifier: 40888277777256
• UDI-Public: 40888277777256
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/29/2026

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: DYNJ51833A
• Device Lot Number: 23DBD348
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/18/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (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