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

Catalog Number	SSN100253
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this needle is not securing onto the syringes and falling off before and after administration.
Additional Manufacturer Narrative
The nurses reported that the needle was not securing onto the syringes and falling off before and after administration; no harm was done to the patient or the nurse.Medline received a complaint for 2bx of the hypodermic safety needle, customer advised that they were using prefilled syringes with the needles, and the reported lot falls under corrective action for needle disconnecting from prefilled syringes; material trending via sap showed similar complaints during the last 12 months.The complaint file does not state that a used sample was evaluated, and the reported problem could not be evaluated from a used sample because none of the used needles were sequestered.Cause was documented as supplier error/comp.Part defective, broke, and medline stated it is working with the vendor to implement corrective actions and will continue to monitor trends.There were no reports of death, serious injury, medical intervention, or follow up care.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: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50802185
• Report Number: 1417592-2026-43284
• Device Sequence Number: 20993630
• Product Code: FMF
• UDI-Device Identifier: 30193489031977
• UDI-Public: 30193489031977
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/16/2026

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
• Device Lot Number: 89721090001
• 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: 12/13/2023
• Initial Report FDA Received Date: 09/17/2026
• 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