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

Catalog Number	SSN100235
Medical Device Problem Codes	Decoupling (1145); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needs twist off the syringe," "needle caps fall off when opening the needle out of the package," and "the safety cap will not stay in open position.".
Additional Manufacturer Narrative
The customer reported multiple needle sticks; the needs twist off the syringe, this has caused the customer to waste vaccine, needle caps fall off when opening the needle out of the package, and the safety cap will not stay in open position.At this time, a sample was not received for investigation, and there were no samples, photos, videos, or other critical details provided, even after follow-ups with the customer; review of the last three trend reports found no trends for the specified material number and its corresponding defect type.The complaint was not confirmed and medline was unable to confirm the complaint issue or that the product failed to meet specifications.Sample required to determine cause; there was no reported death or serious injury associated with this event, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50944757
• Report Number: 1417592-2026-54004
• Device Sequence Number: 9552404
• Product Code: FMI
• UDI-Device Identifier: 30193489031953
• UDI-Public: 30193489031953
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/28/2026

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
• Was Device Available for Evaluation?: No
• 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: 11/07/2023
• Initial Report FDA Received Date: 09/30/2026
• 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