MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LANCET,SAFETY,21G,1.8MM,PUSH BUTTON

Catalog Number	MPHSFTY21Z
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they don't cut as deep and some didn't spring out at all.
Additional Manufacturer Narrative
The customer reported receiving medline pushbutton safety lancets that weren¿t puncturing deep enough and not coming out fully during use, and there was no reported death or serious injury associated with this event.Medline received the pushbutton safety lancets in new condition and randomly selected 80 lancets to test by placing them at the top of five paper sheets with carbon paper placed at the bottom to confirm the needle was puncturing and making a mark after each time they were fired.After testing, each sample triggered as normal and the needle punctured all layers of paper; during testing, no issues were seen and all lancets worked as intended.The complaint was not confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: LANCET,SAFETY,21G,1.8MM,PUSH BUTTON
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945680
• Report Number: 1417592-2026-54119
• Device Sequence Number: 10451575
• Product Code: FMK
• UDI-Device Identifier: 10193489006421
• UDI-Public: 10193489006421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/28/2026

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: MPHSFTY21Z
• Device Lot Number: 84625030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2025
• 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: 07/18/2025
• Initial Report FDA Received Date: 09/30/2026
• 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