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

Catalog Number	DYNJ57823A
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	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hand pack had the chloraprep popped.
Additional Manufacturer Narrative
The account reported finding chloraprep pre activated in the hand pack.A photo and a sample were received; the sample was of just the pack insert & chloraprep, no other pack contents were received, and the investigator observed 4 ea chloraprep that was already pre-activated with the orange solution seeping through the vendor packaging; production records were reviewed and no non-conformances were noted, and there were no issues with the pack build that might have an impact on the issue.The reported problem was confirmed based on the sample evaluation.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; if recurring, change component placement, and the division will monitor for trending.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-HAND PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870319
• Report Number: 1417592-2026-49056
• Device Sequence Number: 10674568
• Product Code: OJH
• UDI-Device Identifier: 40193489237505
• UDI-Public: 40193489237505
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/23/2026

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: DYNJ57823A
• Device Lot Number: 23EMA994
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2023
• 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: 10/12/2023
• Initial Report FDA Received Date: 09/23/2026
• 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