MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NDL 18GX3.5 QUINCKE

Catalog Number	PAIN8021
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "well we have quite a few 18g spinal needles, all the same lot number, that the stylets are hard to remove or will not come out.".
Additional Manufacturer Narrative
The customer reported that the stylets are hard to remove or will not come out, and the facility reported the product was being used to perform an epidural steroid injection when the surgeon had a very difficult time pulling the inner stylet out to be able to inject the radiopaque dye.A sample was received, and the customer provided 15ea for evaluation; the stylet was withdrawn from and then reinserted into the needle to check for any resistance, such as skipping or the need for excessive force.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed, with 5 samples found to be excessively difficult to withdraw and insert the stylet.The root cause for the reported issue has been determined to be due to reduced clearance between the outer and inner needles, resulting from dimensional tolerances and rough inner needle surfaces; 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 18GX3.5 QUINCKE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803767
• Report Number: 1417592-2026-43532
• Device Sequence Number: 16088083
• Product Code: BSP
• UDI-Device Identifier: 10884389848234
• UDI-Public: 10884389848234
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/16/2026

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: PAIN8021
• Device Lot Number: 25D140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2025
• 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: 10/29/2025
• Initial Report FDA Received Date: 09/17/2026
• 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