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

Catalog Number	SYR100257
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, when we go to inject a patient's body part there is a large amount of resistance and cannot push the steroid or lidocaine through the needle.
Additional Manufacturer Narrative
According to the facility, when we go to inject a patient's body part there is a large amount of resistance and cannot push the steroid or lidocaine through the needle.You could not push the last 1cc of medications into the patient.The facility stated it would lead to pulling the needle out and having to reinject the patient.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.Expiration dates (unable to enter more than 1 expiration date in section d- each lot has it's own expiration date): lot 221203: 2027-11-03.Lot 231115: 2028-10-15.Lot 231227: 2028-11-27.

• Common Device Name: NEEDLE,25GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20924838
• Report Number: 1417592-2024-01033
• Device Sequence Number: 17410313
• Product Code: FMI
• UDI-Device Identifier: 40080196305576
• UDI-Public: 40080196305576
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/13/2024

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: SYR100257
• Device Lot Number: 221203, 231115, 231227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown