MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE QUINCKE 22GX5"

Catalog Number	PAIN8123
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 of 10 used so far have been defective, that a piece of black tape on the needle seems to come undone when attempting to use them.
Additional Manufacturer Narrative
The account reported finding defective component, and the issue occurred during use with no injury reported.A photo was received for investigation; the customer provided a photo for review, finished good production records were reviewed, the bill of materials (bom) was reviewed, and component trending was reviewed.Based on the complaint details, photo evaluation, and investigation, the complaint is confirmed; review of the photo confirmed that the needle hub on one of the needles appeared to be warped or crushed.Based on the available information and the lack of additional details, the point at which the defect occurred could not be determined, and a specific root cause could not be identified.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: NEEDLE QUINCKE 22GX5"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818718
• Report Number: 1417592-2026-44650
• Device Sequence Number: 21502843
• Product Code: BSP
• UDI-Device Identifier: 10889942919628
• UDI-Public: 10889942919628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: PAIN8123
• Device Lot Number: 25JBK119
• Was Device Available for Evaluation?: No
• 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: 02/20/2026
• Initial Report FDA Received Date: 09/18/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown