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

Catalog Number	PAIN8021
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needle itself is scraping against the sheath cover when staff pulls it off and it's damaging the needle.".
Additional Manufacturer Narrative
According to the customer, they found that it was difficult to return the stylets into several 18g spinal needles and that it "felt like rubbing sandpaper together"; the customer reported that no patients were "affected by the spinal needle" and there was no serious injury, medical intervention, or follow-up care.Medline quality received samples, visually inspected them for damage, defects and deformities, and evaluated the stylet needles by inserting and reinserting the stylet needle into the sheath.No defects were found during visual inspection; some stylet needles inserted smoothly, while others exhibited scraping during insertion, and medline was able to confirm the complaint.Based on the sample and complaint details, the root cause is considered to be a vendor product issue relating to the manufacturing process; the quality team will monitor this issue for trending purposes and the complaint has been provided to the vendor/manufacturer for further evaluation.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: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947818
• Report Number: 1417592-2026-54496
• Device Sequence Number: 18754967
• Product Code: BSP
• UDI-Device Identifier: 10884389848234
• UDI-Public: 10884389848234
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/17/2026

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: 25A122
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2025
• 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: 07/17/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown