MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-REMOVER,STAPLE,SKIN,STERILE

Catalog Number	DYNJ04058
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staple remover is not properly removing staples.The pin that connects the piece is loose.
Additional Manufacturer Narrative
The account reported finding defective staple remover, and the complaint stated the pin that connects the piece is loose and each site has the same loose staple removers; the issue did not occur during use and no injury occurred.Medline received an unused stapler remover for sample review, reviewed finished good production records and finished good pack build, and functionally tested the staple remover by inserting staples into a skin pad and attempting to remove them.The reported problem was confirmed: the staple remover handles were loose and did not hold shape, the pin that holds the two together did appear loose, and the staples did not remove in one piece, if at all, as the remover did not grip the staples properly.This component is not altered before being placed into the kit and the root cause is considered to be a component manufacturing product issue relating to the components manufacturing process; the division will monitor this issue 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-REMOVER,STAPLE,SKIN,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872986
• Report Number: 1417592-2026-49403
• Device Sequence Number: 9314223
• Product Code: GDT
• UDI-Device Identifier: 10080196846924
• UDI-Public: 10080196846924
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: DYNJ04058
• Device Lot Number: 23EBM844
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2025
• 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: 08/01/2025
• 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