MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,25GX1.5",REG,BEVEL

Catalog Number	SYR100257Z
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4 boxes of needles were "stopping up before completely empty.".
Additional Manufacturer Narrative
The customer reported receiving a medline needle that is stopping before completely empty, and reported 4 boxes of needles "stopping up before completely empty"; there was no reported death or serious injury associated with this event.A sample was not received for investigation; investigation included review of recent complaint trends/scar activity for the last three trend reports, and the vendor reviewed records and retained samples.The complaint was not confirmed because the issue can only be confirmed by further investigating the sample or a provided photo, and no root cause was identified.No abnormalities were found in the retained samples of this batch and the production process after investigation, no trends were identified for the specified material number and corresponding defect type, and the division will continue to monitor trends.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,25GX1.5",REG,BEVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872885
• Report Number: 1417592-2026-49381
• Device Sequence Number: 18809943
• Product Code: FMI
• UDI-Device Identifier: 10080196305575
• UDI-Public: 10080196305575
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K233037
• 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): 09/23/2026

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: SYR100257Z
• Device Lot Number: 250910
• Was Device Available for Evaluation?: Yes
• 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: 03/18/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown