MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-RESPIRATORY ICU BRONCHOSCOPY

Catalog Number	DYKE1973
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have received the broch kits improperly packaged.The entire case was received like this.".
Additional Manufacturer Narrative
The account reported finding open perforation pouch, and the complaint transcript states the issue did not occur during use and no injury occurred.Photos were provided for evaluation; finished good production records, finished good pack build, and trending were reviewed.The photos demonstrate the clear perf bags visibly open on the seam of the two sides of the bag, confirming the reported issue.Based on the complaint details, the pouch was damaged on an outside source at some point during production, transit, or storage; although the reported issue was confirmed, medline was unable to determine at what point the damage occurred, and the division 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: DBD-RESPIRATORY ICU BRONCHOSCOPY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884953
• Report Number: 1417592-2026-50105
• Device Sequence Number: 10744751
• Product Code: OGR
• UDI-Device Identifier: 10195327691905
• UDI-Public: 10195327691905
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/22/2026

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: DYKE1973
• Device Lot Number: 25FLA691
• 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: 02/06/2026
• Initial Report FDA Received Date: 09/24/2026
• 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