MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE STANDARD HYPODERMIC NEEDLE; NEEDLE,25GX1.5",REG,BEVEL

Catalog Number	SYR100257
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, during a procedure with a steroid injection, they drew 3ml of lidocaine through the needle, site was located through ultrasound, and provider proceeded to attempt to inject the steroid.He was met with abnormal resistance and removed the needle and tried to expel and then discovered the blockage.Another needle needed to be used for injection, patient had to endure additional pokes, and pt also experienced a prolonged procedure, which was able to be completed.Facility states there was no serious injury.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
According to the facility, on (b)(6) 2025, during a procedure with a steroid injection, they drew 3ml of lidocaine through the needle, site was located through ultrasound, and provider proceeded to attempt to inject the steroid.He was met with abnormal resistance and removed the needle and tried to expel and then discovered the blockage.
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer.Updated h6: type of investigation (b).Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).

• Brand Name: MEDLINE STANDARD HYPODERMIC NEEDLE
• Common Device Name: NEEDLE,25GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24111608
• Report Number: 1417592-2026-00057
• Device Sequence Number: 17494632
• Product Code: FMI
• UDI-Device Identifier: 10080196305575
• UDI-Public: 10080196305575
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K180417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: SYR100257
• Device Lot Number: 240303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 118 KG