MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NDL 20GX3.5 TUOHY RW METAL

Catalog Number	PAIN8009
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles being excessively dull" and "the issue persists.".
Additional Manufacturer Narrative
The customer reported "the needles being excessively dull," which "resulted in increased discomfort for our patients," and stated that the issue persists.A sample was received for investigation; the customer returned 3ea for evaluation, medline cannot test the samples based on the nature of the reported defect, production records were requested from the manufacturer, and no investigation was received from the manufacturer after two follow ups.Based on the complaint details and the investigation, the complaint is not confirmed.The manufacturer of the product has been notified, the samples will be forwarded to them for further evaluation, and the division will monitor this issue 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: NDL 20GX3.5 TUOHY RW METAL
• 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: 50897027
• Report Number: 1417592-2026-50796
• Device Sequence Number: 17605548
• Product Code: BSP
• UDI-Device Identifier: 10884389622247
• UDI-Public: 10884389622247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110194
• 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): 09/24/2026

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: PAIN8009
• Device Lot Number: 23J341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2025
• 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: 11/18/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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