MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2; HYPODERMIC NEEDLE

Model Number	11812705
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
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 complaint information was reviewed: no samples/pictures available for investigation.Lot of impacted monoject 1ml syringe w/hypodermic safety needle 27g x ½", ref 11812705 is not available.Archive sample evaluation: it is not possible to perform an archive sample analysis.Risk statement: the overall risk assessment, given the severity assessment of s3-moderate injury and a probability assessment of p2-low, the final risk priority number is 6.Risk level is in green area/low risk according to our risk management procedure.
Event or Problem Description
Customer reported that miltiple providers have had the needle stuck in the skin of infant when finishing injecting and removing needle.Materials management is in process of contacting the vendor to return the product.

• Common Device Name: HYPODERMIC 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: 14761890
• Report Number: 3014312726-2022-00007
• Device Sequence Number: 4999799
• Product Code: FMI
• UDI-Device Identifier: 10884521544796
• UDI-Public: 10884521544796
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11812705
• Device Catalogue Number: 11812705
• Device Lot Number: UNKNOWN
• 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: 05/11/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown