MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 23GX1

Catalog Number	SSN100235
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one of the mas was administering a vaccine and wasn¿t able to get the medicine to flow completely out of the needle.At a certain point the needle seemed to jam.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 "the needle seemed to jam" and they were "not able to push the medication through the needle"; the needle was replaced and the patient was able to receive their "vaccination", but the patient was "stuck twice" due to the reported issue.Medline received 24 samples in new condition; upon visual inspection, no manufacturing or other defects were found preventing the samples to work properly, and testing found the plungers smoothly allowed all the water out, the water flow remained uninterrupted, and no clogging or jamming of the needles was noted.The complaint was not confirmed.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.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,HYPODERM,SAFETY, 23GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50882447
• Report Number: 1417592-2026-49695
• Device Sequence Number: 18598671
• Product Code: FML
• UDI-Device Identifier: 10193489031959
• UDI-Public: 10193489031959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• 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: SSN100235
• Device Lot Number: 89724100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2025
• 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: 05/02/2025
• Initial Report FDA Received Date: 09/24/2026
• 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