MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. HENRY SCHEIN SAFETY NEEDLE 25G*1 1/2"

Model Number	900-7656
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports that a pre-procedure prep of lidocaine was being administered to a (b)(6) male patient.The procedure scheduled was a lumbar epidural steroid injection.The procedure was not performed due to the needle coming out of the hilt/hub.The needle then became lodged in the soft tissue of the patient's lumbar.As a result the patient was sent to the operating room on (b)(6) 2022.The same day, on (b)(6) 2022 the patient was discharged.The patient is doing well as of today.The pain they are experiencing is being controlled by otc.The one using this has used these type before.
Additional Manufacturer Narrative
The complaint device was not to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.The production site checked the batch record of impacted safety needle 25g x 1 ½", ref 900-7656, lot 02103067 with no anomalies found.No samples were received by the customer for evaluation.Archive sample evaluation: traction test: 10pcs have been checked for traction test between cannula and needle hub.All samples are within product specification requirements (max.Deflection 0.4mm for tw).Resistance to breaking test: 10pcs have been tested in accordance with iso 9626:2016 annex c.All samples passed the test.Stiffness test: 10pcs have been tested in accordance with iso 9626:2016 annex b.All samples are within product specification requirements (max.Deflection no anomalies were found on archive samples checked.Risk statement: the overall risk assessment, given the severity assessment of s3-moderate injury and a probability assessment of p1-very low, the final risk priority number is 3.Risk level is in green area/low risk according to our risk management procedure.

• Common Device Name: SAFETY NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer Contact: shari wiley ; 315 shawnee north drive; suite 100; suwanee, GA 30024 ; 4049732200
• MDR Report Key: 14892657
• Report Number: 3014312726-2022-00002
• Device Sequence Number: 2032234
• Product Code: FMI
• UDI-Device Identifier: 00304040017302
• UDI-Public: 00304040017302
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: 900-7656
• Device Catalogue Number: 9007656
• Device Lot Number: 021030067
• 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: 06/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown