MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-KNEE ARTHROSCOPY PACK

Catalog Number	DYNJ62169B
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that chloraprep wand not protected and activated prior to case.
Additional Manufacturer Narrative
The account reported finding preactivated chloraprep, and the detailed description of the concern stated that the chloraprep wand was not protected and activated prior to case; the incident did not occur during patient use.A photo was received as a sample to aid in the investigation, finished good production records were reviewed, finished good pack build was reviewed, trending was reviewed, and no remaining inventory of the pack lot was available to check for defects.Based on the complaint details, photo evaluation, and investigation, medline confirmed the chloraprep leaked inside of the pack; the account later returned one full unopened pack, and evaluation clearly observed one of the chloraprep's orange solution was preactivated and leaked out.The placement of the chloraprep in the pack was determined to be in a location which provides adequate protection from pre-activation, and it is possible that the activation point may inadvertently become compressed and the component activated at some point during transit or storage; rough handling and certain placement of the item will increase the likelihood of this occurring.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-KNEE ARTHROSCOPY PACK
• 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: 50777974
• Report Number: 1417592-2026-41236
• Device Sequence Number: 21509052
• Product Code: OJH
• UDI-Device Identifier: 40193489952064
• UDI-Public: 40193489952064
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/15/2026

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: DYNJ62169B
• Device Lot Number: 23FMH454
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2024
• 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: 12/21/2023
• Initial Report FDA Received Date: 09/15/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown