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

Catalog Number	DYNJ85496A
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	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "she recieved two 1 cs (2 each) of crushed chloraprep¿s within the packs.".
Additional Manufacturer Narrative
The customer stated that she received two 1 cs (2 each) of crushed chloraprep¿s within the packs, and the account reported finding chloraprep preactivated.No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted, and finished good pack build was reviewed with no issues noted that might have an impact on the issue.Medline was not able to confirm the defect as there were no samples or detailed pictures received for this complaint investigation.Without a sample it is difficult to determine a true root cause for the reported issue; the complaint was provided to the vendor for further evaluation and supplier quality will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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: TOTAL KNEE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869283
• Report Number: 1417592-2026-48821
• Device Sequence Number: 13106377
• Product Code: LRO
• UDI-Device Identifier: 40195327629404
• UDI-Public: 40195327629404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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: DYNJ85496A
• Device Lot Number: 24FBB589
• Was Device Available for Evaluation?: Yes
• 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: 09/16/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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