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

Catalog Number	MPHSAFETY281
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles are not coming out of the end to draw blood".
Additional Manufacturer Narrative
The customer stated the lancets are defective and that the needles are not coming out of the end to draw blood.Medline received 20 boxes of push button safety lancets in used condition and tested 5 lancets from each box by twisting off the safety tab, placing the lancet on a stack of 5 sheets of paper with a piece of carbon paper in the middle, and pressing the push button to trigger the lancet.All lancets tested operated as normal, with the needle firing once into the stack of paper and retreating back into the lancet housing, and the complaint was not confirmed.The cause was documented as not confirmed with received sample, 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.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-LANCET,SAFETY,28G,1.6MM,PUSH BUTTON
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945436
• Report Number: 1417592-2026-54076
• Device Sequence Number: 21445606
• Product Code: FMK
• UDI-Device Identifier: 40888277333902
• UDI-Public: 40888277333902
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: MPHSAFETY281
• Device Lot Number: C56E937E5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2023
• 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: 10/23/2023
• 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