MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HYPERINFLATION SYSTEM 1L-LF

Catalog Number	DYNJAAHY609
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported 3 defective 1-liter jackson reese and that they all have tears in the breathing bag portion of the circuit.A sample was received for investigation; on all samples, the breathing bag is torn at the connection to the tail-end valve, and the tears range in size from 3cm to completely torn off; finished good production records and finished good pack build were reviewed, with no issues that would contribute to the reported issue.The reported complaint was confirmed, and based on the complaint details, the root cause is considered to be a product issue relating to the component assembly process.Our quality team will monitor this issue for trending purposes, production and qc managers have been notified of the reported issue, 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.
Event or Problem Description
It was reported that "i have 3 defective 1 liter jackson reese with the lot number of 22lbj367.They all have tears in the breathing bag portion of the circuit.".

• Brand Name: MEDLINE
• Common Device Name: HYPERINFLATION SYSTEM 1L-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945551
• Report Number: 1417592-2026-54099
• Device Sequence Number: 9552044
• Product Code: LRO
• UDI-Device Identifier: 10193489567328
• UDI-Public: 10193489567328
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: DYNJAAHY609
• Device Lot Number: 22LBJ367
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2024
• 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: 08/22/2024
• Initial Report FDA Received Date: 09/30/2026
• 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