MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LANCET,HEEL,NEWBORN,1.0MM D, 2.5MM L

Catalog Number	MPHNEWBORN2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after a heel stick this morning the nurse was cleaning up the ved and found the "min razor blade" that fell out of the nancet.".
Additional Manufacturer Narrative
The nurse was completing a heel stick on a patient, used the product as instructed, obtained the lab, and when cleaning up her bedspace she saw the little blade sitting next to the heel lancet; no serious injury identified, medical intervention required, or follow-up care needed.Medline received 1ea infant heel incision device in used condition, randomly selected 25 samples to perform visual and functional testing, and visual inspection revealed no manufacturing defects preventing the samples to work as intended; functional testing experienced no issues, the incision mark was clearly visible, and the cutting mechanism was fully retracted as intended.The complaint was confirmed and the sample received showed that the needle was disconnected from the device, though testing did not reveal any defects and medline was unable to recreate the issue the customer experienced.Medline was not able to determine the root cause of the issue; material trending via sap showed no similar complaints during the last 12 months, and division has been informed and will continue to monitor trends.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,HEEL,NEWBORN,1.0MM D, 2.5MM L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886274
• Report Number: 1417592-2026-50304
• Device Sequence Number: 10704880
• Product Code: FMK
• UDI-Device Identifier: 30888277661190
• UDI-Public: 30888277661190
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210745
• 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: MPHNEWBORN2
• Device Lot Number: 75822090006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2023
• 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: 04/24/2023
• 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