MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FORCEP SPLINTER FINE 4.5

Catalog Number	DYND04046
Medical Device Problem Codes	Contamination (1120); Moisture Damage (1405)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we received a case of splinter forceps that appeared to have been exposed to moisture and were beginning to show signs of mold.The product inside exhibited visible contamination.The sterile seal was discolored and gritty, and the top of the packaging showed clear evidence of water damage.".
Additional Manufacturer Narrative
The account reported finding moisture damage; the customer reported that the product inside exhibited visible contamination, the sterile seal was discolored and gritty, and the top of the packaging showed clear evidence of water damage.A sample was received for investigation; medline received 1 case of item dynd04046 forcep splinter fine 4.5 which were all unopened, reviewed finished good production records, reviewed the finished good pack build, and reviewed trending.No moisture damage was observed on the outside of the case, black markings on the top of the kit labeling looked to be ink transfer, and no moisture damage or water was observed.Medline was unable to confirm the reported issue with the sample received, was unable to confirm the root cause, and division will monitor 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: FORCEP SPLINTER FINE 4.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867867
• Report Number: 1417592-2026-48640
• Device Sequence Number: 10716002
• Product Code: LRO
• UDI-Device Identifier: 10884389649503
• UDI-Public: 10884389649503
• 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: DYND04046
• Device Lot Number: 25DBH366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2025
• 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: 05/21/2025
• 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): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown