MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LANCET,SAFETY,28G,1.6MM,PUSH BUTTON

Catalog Number	MPHSFTY28Z
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "needle is not coming out of device.Product is defective.".
Additional Manufacturer Narrative
The customer called to state needle is not coming out of device and product is defective.Medline received the safety lancets in like-new condition, randomly selected 25 lancets to perform a visual inspection and functional test, and the visual inspection revealed no manufacturing or any other defects; all lancets tested operated as normal, with the needle firing once into the stack of paper and retreating back into the lancet housing.The investigation results were unconfirmed, and the complaint was not confirmed.The cause was listed as not confirmed with received sample; based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and the lancets worked as intended.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,28G,1.6MM,PUSH BUTTON
• 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: 50884519
• Report Number: 1417592-2026-50029
• Device Sequence Number: 9791929
• Product Code: FMK
• UDI-Device Identifier: 00193489006448
• UDI-Public: 00193489006448
• 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): 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: MPHSFTY28Z
• Device Lot Number: 84624040003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2024
• 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: 08/05/2024
• Initial Report FDA Received Date: 09/24/2026
• 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