MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEEDLE,22GX1.5",REG,BEVEL

Catalog Number	SYR100227Z
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the facility "the needles are getting stuck; they stop delivering meds towards the end of the injection and prevent the provider from giving the whole injection without having to restick the patient".No additional information is available at this time.A sample was returned for evaluation and the reported issue was not confirmed, and unable to be replicated.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
Full dose of medication not being administered.

• Common Device Name: NEEDLE,22GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21066518
• Report Number: 1417592-2025-00002
• Device Sequence Number: 14300485
• Product Code: FMI
• UDI-Device Identifier: 30080196305531
• UDI-Public: 30080196305531
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/03/2025

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?: No
• Device Catalogue Number: SYR100227Z
• Device Lot Number: 240425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown