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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M LUER LOCK SYRINGE
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SOL-MILLENNIUM MEDICAL INC SOL-M LUER LOCK SYRINGE Back to Search Results
Model Number P180001PP
Device Problems Fracture (1260); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Reporter withdrew 0.3 ml of air into the syringe and pushed air into modena covid vaccine vial (dose was to be 0.25 ml).Once reporter began to draw vaccine to 0.5 ml to be have extra vaccine to prime hub and needle, the plunger of the the syringe became trapped at the 0.46 ml line.Reporter attempted to draw back more vaccine to see what was wrong with the syringe, and the plunger was hard to pull from 0.46 to 0.66 ml lines, the syringe was bent and cracked around this measurement causing the plunger to become pressurized between 0.46 go 0.66, causing forced air bubbles to form from the bottom of the syringe to the top.Reporter pushed all vaccine contents back into the vial and removed the syringe and gave it to charge nurse for a second witness on the malfunctioning syringe.Charge nurse watched reporter draw vaccine again with the same syringe and confirmed it was a malfunctioning product.
 
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Brand Name
SOL-M LUER LOCK SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
SOL-MILLENNIUM MEDICAL INC
311 s wacker dr, suite 4100
chicago IL 60604
Manufacturer (Section G)
SOL-MILLENNIUM MEDICAL INC
311 s wacker dr, suite 4100
chicago IL
Manufacturer Contact
jarryd franklin
MDR Report Key18476047
MDR Text Key333019882
Report Number3014312726-2024-00052
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberP180001PP
Was Device Available for Evaluation? Yes
Patient Sequence Number1
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