MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,30GX0.5"REG,BEVEL

Catalog Number	SYR100302
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the provider went to use the needle, the needle was not protected in the cap.The needle was sticking out past the cap causing the provider to be stuck by it.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 a provider was poked by a capped needle that was sticking out through the plastic cap; the stick was reported on the left thumb, the needle was clean, and the provider did not require any post exposure tasks.No samples were received for investigation, but a lot # was provided; reserve stock from the same lot was ordered, and 25 samples were randomly selected for a visual inspection and functional testing by attaching the needles to medline luer lock syringes and inserting the samples into a training pad for hub testing.The visual inspection revealed no manufacturing or any other defects preventing the samples to work as intended, all the needles remained covered by their safety cap within the sterile packaging, and no needles protruding from the cap or the cap detaching from the needle when attached to the hub was experienced.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications; no root cause was identified, and the samples worked as intended.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,30GX0.5"REG,BEVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754683
• Report Number: 1417592-2026-39272
• Device Sequence Number: 9148868
• Product Code: FMI
• UDI-Device Identifier: 40080196305637
• UDI-Public: 40080196305637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112057
• 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): 09/11/2026

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: SYR100302
• Device Lot Number: 220922
• 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: 04/24/2023
• Initial Report FDA Received Date: 09/14/2026
• 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