MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 25GX5/8

Catalog Number	SSN100253
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that needle cap falls off when removing from packaging, the safety device will not stay in an open position.The needles are twisting itself off the syringe which has happen with both plastic and glass syringes.
Additional Manufacturer Narrative
The customer reported the needle cap falls off when removing from packaging, the safety device will not stay in an open position, this has caused needle sticks, and the needles are twisting itself off the syringe with both plastic and glass syringes, causing wasted vaccines and medications.At this time, a sample was not received for investigation, no lot/serial number was provided by the account, and the review of the last three trend reports was completed.The complaint was not confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.The cause code is unconfirmed defect, sample required to determine cause, and there was no reported death or serious injury associated with this event.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, 25GX5/8
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50785955
• Report Number: 1417592-2026-41803
• Device Sequence Number: 21465076
• Product Code: FMF
• UDI-Device Identifier: 30193489031977
• UDI-Public: 30193489031977
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/15/2026

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: SSN100253
• 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: 01/02/2024
• Initial Report FDA Received Date: 09/16/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown