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

Catalog Number	SYR100257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, the "product was being used for a thyroid biopsy" and "in the process of trying to retrieve specimen, needle broke off at the hub from cytocore machine" into "the patient's thyroid." the facility noted the patient had a "3.8cm thyroid nodule" preexisting the reported incident.The facility reported, "patient underwent imaging (ct and x-ray) to confirm the location of needle in thyroid bed." the facility stated, "patient transferred to hospital to have needle surgically removed from patient's thyroid bed." the facility reported that the patient is "recovering and ok at this time." no additional information is available regarding the reported incident at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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) 2026, the "product was being used for a thyroid biopsy" and "in the process of trying to retrieve specimen, needle broke off at the hub from cytocore machine" into "the patient's thyroid.".
Additional Manufacturer Narrative
Updated h10: related report numbers.

• 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: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24966203
• Report Number: 1417592-2026-00548
• Device Sequence Number: 18757951
• Product Code: FMI
• UDI-Device Identifier: 10080196305575
• UDI-Public: 10080196305575
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K233037
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 250714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White