MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-QUICK KIT

Catalog Number	DYNJ66437A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "miscount lap sponges".
Additional Manufacturer Narrative
The account reported finding miscount lap sponges in the dbd-quick kit.No sample or photo received for the investigation; finished good production records were reviewed and no non-conformances were noted that would have contributed to the reported issue, and finished good pack build was reviewed with no issues that might have an impact on the issue.The reported problem could not be evaluated with a sample or photo because none was received.Based on the complaint details it is likely the miscount was a human error during the manual pack assembly process; lap sponges are now double banded as a corrective action, and a risk assessment was completed and the incident was found to be acceptable.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-QUICK KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50226178
• Report Number: 1417592-2026-16171
• Device Sequence Number: 13327353
• Product Code: FDE
• UDI-Device Identifier: 40195327105946
• UDI-Public: 40195327105946
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 08/12/2026

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: DYNJ66437A
• Device Lot Number: 24ABG345
• 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: 05/29/2024
• Initial Report FDA Received Date: 08/12/2026
• 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