MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-RR-HN INCISIONAL PACK-LF

Catalog Number	DYNJ0152036L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "raytec sponge pack with 6 sponges instead of 10." "another sample received under this lot # 8 instead of 10.".
Additional Manufacturer Narrative
¿it was reported that¿the¿ raytec sponge pack with 6 sponges instead of 10, 8 instead of 10.¿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-RR-HN INCISIONAL PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50214160
• Report Number: 1417592-2026-15654
• Device Sequence Number: 14977061
• Product Code: LRO
• UDI-Device Identifier: 40195327415687
• UDI-Public: 40195327415687
• 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): 08/11/2026

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: DYNJ0152036L
• Device Lot Number: 24AME447
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/10/2024
• 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: 04/25/2024
• Initial Report FDA Received Date: 08/11/2026
• 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