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

Catalog Number	SSN100253
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "drawing up a varicella vaccine and when i inserted the needle into the rubber hub the needle (metal piece only) snapped off and dropped onto the counter.No harm was done at the time, but if this needle had been inserted into a patient it would have snapped off and been in the patients leg or arm.".
Additional Manufacturer Narrative
The report states, "drawing up a varicella vaccine and when i inserted the needle into the rubber hub the needle (metal piece only) snapped off and dropped onto the counter.No harm was done at the time, but if this needle had been inserted into a patient it would have snapped off and been in the patients leg or arm." customer reported, "needle was inserted into the rubber hub, the needle snapped off and dropped onto the counter.Broken needle and remainder was disposed of in sharps container.Safe haven was entered by medical assitant." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• 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: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50713414
• Report Number: 1417592-2026-09747
• Device Sequence Number: 21479322
• Product Code: FMF
• UDI-Device Identifier: 10193489031973
• UDI-Public: 10193489031973
• 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): 09/10/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SSN100253
• Device Lot Number: 89726030001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown