MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 25GX1

Catalog Number	SSN100255
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when twisting in the needle, it would unseat the connector.The barrel length seems to be the issue as the covidien is shorter and does not do this.".
Additional Manufacturer Narrative
It was reported that when attaching the needle to the "prefilled flu vaccine syringes" on (b)(6) 2024 the "barrel bottoms out when installing the luer lock needle and causes the prefilled syringe adapter to crack and/or unseat exposing vaccine"; the customer reported that there was no patient involvement, and the patient was able to receive their vaccination with a different syringe and needle.Medline received a complaint for 1ea of hypodermic safety needle, sample/photo provided was no, and material trending via sap showed similar complaints during the last 12 months.The division has been informed and will continue to monitor trends, and the complaint was closed.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, 25GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50844874
• Report Number: 1417592-2026-46789
• Device Sequence Number: 9949361
• Product Code: FMF
• UDI-Device Identifier: 30193489031984
• UDI-Public: 30193489031984
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/18/2026

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: SSN100255
• Device Lot Number: 89721070001
• 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: 10/22/2024
• Initial Report FDA Received Date: 09/21/2026
• 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