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, a provider was performing a steroid injection using a 25g x 1.5" needle.After drawing 3 ml of lidocaine and identifying the injection site via ultrasound, the provider attempted to administer the medication but encountered abnormal resistance.A second injection site was attempted with the same result.The needle was then removed, and a blockage was identified when attempting to expel the medication.A second 25g x 1.5" needle was used on the patient and failed in the same manner.A third needle from the same lot was tested but not used on the patient; saline could be drawn into the syringe but could not be expelled due to severe resistance.The facility subsequently switched to a 25g x 1" needle from a different lot and completed the injection.The patient received three additional needle sticks due to the malfunctioning devices, extending the procedure, but no serious injury occurred.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, a provider was performing a steroid injection using a 25g x 1.5" needle.After drawing 3 ml of lidocaine and identifying the injection site via ultrasound, the provider attempted to administer the medication but encountered abnormal resistance.A second injection site was attempted with the same result.The needle was then removed, and a blockage was identified when attempting to expel the medication.A second 25g x 1.5" needle was used on the patient and failed in the same manner.A third needle from the same lot was tested but not used on the patient; saline could be drawn into the syringe, but could not be expelled due to severe resistance.The facility subsequently switched to a 25g x 1" needle from a different lot and completed the injection.The patient received three additional needle sticks due to the malfunctioning devices, extending the procedure, but no serious injury occurred.
Additional Manufacturer Narrative
Update to d9, h3, and h6.After further investigation, it has been determined that the investigation involved trend analysis and testing of the actual/suspected device.The sample was returned and evaluated on 1/5/26.No device problem was found nor detected.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE STANDARD HYPODERMIC NEEDLE
• Common Device Name: NEEDLE,25GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24108799
• Report Number: 1417592-2026-00054
• Device Sequence Number: 5878781
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/06/2026
• Is the Reporter a Health Professional?: No
• 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: 04/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 118 KG