MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,21GX1.5

Catalog Number	SSN100217Z
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿it feels as if they're not as sharp as they should be.Normally when i inject someone, the needle goes in like butter, but these needs i can feel them stall at first then i almost feel them going through the muscle.¿.
Additional Manufacturer Narrative
Customer reported that, ¿when using the needle, they feel like they ¿catch¿ in the skin/muscle instead of gliding smoothly,¿ and the customer reported increased patient ¿pain¿ during injections, but no re-sticks were required.Medline received 1bx (b)(6), noted no obvious signs of defect or damage upon initial investigation, and inspected multiple needle tips under a microscope, finding at least 1 needle with the very tip of the needle being slightly bent backward; the manufacturer also reviewed records and retain samples.The complaint is confirmed.The cause was documented as ¿cannot determine cause w/received sample,¿ and the vendor stated that dhr inspection found no abnormalities, no deviation, and no non conformities during the manufacturing process, while also stating it is speculated that the user collided with the tip of the protective cap when removing it, causing burrs on the needle tip.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,21GX1.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773350
• Report Number: 1417592-2026-40574
• Device Sequence Number: 10615026
• Product Code: FMI
• UDI-Device Identifier: 10193489031928
• UDI-Public: 10193489031928
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Device Catalogue Number: SSN100217Z
• Device Lot Number: 89725030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2025
• 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: 10/03/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown