MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NDL, WHITACRE SPINAL, 22GX3.5"

Catalog Number	PAIN8015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that these needles bend when going into patient arm.
Additional Manufacturer Narrative
The account reported that the needles bend when going into a patient¿s arm.A sample was received for investigation; the sample consisted of five boxes of the reported product, four of the boxes were sealed and one box was opened, and all of the needles in the open box remained in their individually sealed packages.Trending was reviewed and there were 0 additional reported complaints for this account/issue and 0 additional reported complaints for this component issue in the past 6 months; with the information and samples provided, medline was not able to confirm the quality complaint.The intended use of the product conflicts with the product use in the complaint, the cause code was updated to reflect traced to user - misuse/mishandling, and the supplier quality team 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, WHITACRE SPINAL, 22GX3.5"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50675136
• Report Number: 1417592-2026-34241
• Device Sequence Number: 20153442
• Product Code: BSP
• UDI-Device Identifier: 40889942474135
• UDI-Public: 40889942474135
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/04/2026

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: PAIN8015
• Device Lot Number: 22H200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2023
• 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: 02/23/2023
• Initial Report FDA Received Date: 09/08/2026
• 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