MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ANTERIOR HIP

Catalog Number	DYNJ909640A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one of the chloraprep sticks in each pack was cracked".
Additional Manufacturer Narrative
The account reported that one of the chloraprep sticks in each pack was cracked and had to be discarded.A photo was received for the investigation, finished good production records were reviewed, and the finished good pack build was reviewed; no non-conformances were noted and there were no issues with the pack build that might have an impact on the issue.The photo shows the account holding a chloraprep stick that had activated inside the vendor packaging; the root cause was listed as mishandling by manufacturer or can't determine.The placement of the chloraprep in the pack was determined to be in a location which provides adequate protection from pre-activation, and the complaint was provided to the vendor for further evaluation while supplier quality monitors 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-ANTERIOR HIP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50713454
• Report Number: 1417592-2026-35646
• Device Sequence Number: 10640959
• Product Code: OJH
• UDI-Device Identifier: 40195327469048
• UDI-Public: 40195327469048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2026

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: DYNJ909640A
• 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: 12/04/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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