MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT 1ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*5/8

Model Number	11812558
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when he was placing a tb skin test and had engaged the safety which puts a cover over the top portion.Per customer, he went to put the cap on to discard and noticed that the safety disengaged.He was able replcate it with 2 other needles,the safety disengages with light pressure.There was no harm reported.
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 were available for investigation.

• Common Device Name: LUER LOCK SYRINGE W/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: 14762594
• Report Number: 3014312726-2022-00006
• Device Sequence Number: 4999800
• Product Code: FMF
• UDI-Device Identifier: 10884521544819
• UDI-Public: 10884521544819
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101359
• 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: 11812558
• Device Catalogue Number: 11812558
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown