MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; NEEDLE, QUINCKE, 25GX3.5"

Catalog Number	PAIN8018
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2026, it was reported that "as the tech was opening the needle to put it on the sterile tray, the package ripped about halfway down the package causing the needle to either touch the outside packaging or their hand.After this action occurred another needle had to be opened so that there was no risk for adding a contaminated needle to the sterile field." there was no reported injury or death, and no follow-up care, medical, and/or surgical intervention or treatment required.
Event or Problem Description
Package ripped about halfway down the packaging, causing the needle to become unsterile.
Additional Manufacturer Narrative
Added h6 (b) investigation types, but there was no change to the findings or conclusion.

• Brand Name: MEDLINE
• Common Device Name: NEEDLE, QUINCKE, 25GX3.5"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24875198
• Report Number: 1417592-2026-00419
• Device Sequence Number: 10028821
• Product Code: BSP
• UDI-Device Identifier: 10884389622278
• UDI-Public: 10884389622278
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN8018
• Device Lot Number: 25KBM792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown