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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the inside stylet piece is super hard to get out and in with a lot of the needles" and "some of them are physically stuck and won't budge at all.".
Additional Manufacturer Narrative
The account reported finding that the stylet piece is super hard to get out, and according to the customer, during the set-up of a sterile field in the operating room, the inner stylet of the needle was "very hard to remove from the needle" and if it was removed "it wouldn¿t go back in very easily." medline quality received three boxes, and the samples were visually inspected; the needle stylets were in a locked position and the hub for the needle stylet was attempted to be removed but was unable to get the needle stylet out of the stuck/locked position.The complaint was confirmed.While dimensional measurements were within specifications, the cause of the inner needle sticking was due to the clearance between the outer and inner needles becoming narrower and the inner needle surface being rough; therefore, measures were implemented to increase the product clearance and suppress interference between the outer and inner needles.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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947040
• Report Number: 1417592-2026-54377
• Device Sequence Number: 13374888
• Product Code: BSP
• UDI-Device Identifier: 10884389848234
• UDI-Public: 10884389848234
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/29/2026

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: 25A121
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2025
• 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: 06/19/2025
• 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