MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-M BLUNT FILL NEEDLE 18G*1 1/2"; BLUNT FILL NEEDLE & FILTER NEEDLE

Model Number	18G*1 1/2
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
I am a practicing anesthesiologist in (b)(6).While working at an endoscopy center, i recently observed a bit of debris floating in a syringe of propofol that i had drawn up.I set the syringe aside; it never touched the patient.Later investigation reveals that the 18 gauge blunt needle used to pierce the polymer stopper on the vial had apparently cored the stopper and that the debris seen was the polymer core.One can only speculate what harm might have come to the patient if the debris had been injected into a vein.Perhaps it may have benignly lodged in a capillary bed in the lung and never have caused a problem.Perhaps it may have become the nidus of an infection or clot formation, and perhaps it may have slipped through a patent foramen ovale and been swept into the coronary or cerebral circulation.In any case, this would seem to be a reportable event.Regarding technique, i am happy to report that i had done everything by the book as i do every time.I used a new single use needle, a new unaccessed vial of propofol, and a new single use syringe.I swabbed the stopper on the vial with a 70% isopropyl alcohol pad immediately prior to access.Note that propofol cannot be drawn through a filter needle.I have retained the vial in question, the recovered debris, and a needle from the same batch as the needle used.(i had already disposed of needle when i noticed the debris in the syringe).I have photographs taken of all components at the time of the incident.I have a photo showing the bit of debris in the syringe just between the 1 and 2 ml markings on the syringe, and the vial with stopper and prominent visible point of puncture.Image 4541 shows the debris as seen in the vial image 4540 shows all of the components used in the system for drawing medication.Note the more prominent than normal puncture site on the via stopper.Image 4544 shows a close up of the vial label image 4545 shows the back side of the vial label image 4551 shows the recovered debris (the core from the vial stopper) image 4558 shows the debris as seen through a student microscope on low power.

• Common Device Name: BLUNT FILL NEEDLE & FILTER NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee norrth drive; suite 100; suwanee 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north drive; suite 100; suwanee 30024
• Manufacturer Contact: wiley ; 315 shawnee north drive; suite 100; suwanee 30024 ; 8336370857
• MDR Report Key: 16512917
• Report Number: 3014312726-2023-00002
• Device Sequence Number: 17721125
• Product Code: GAA
• UDI-Device Identifier: 00818392015294
• UDI-Public: 00818392015294
• Combination Product (Y/N): N
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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 Model Number: 18G*1 1/2
• Device Catalogue Number: 110022
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/09/2023
• 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: Required Intervention
• Patient Sex: Unknown