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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
Writer took syringe out of syringe bundle that was secured by rubber band, and when writer was drawing up vaccine, writer noticed that plunger had resistance when drawing up vaccine and found a crack approximately 1 cm in length along the syringe.
 
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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 Key18476006
MDR Text Key332445940
Report Number3014312726-2024-00050
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberP180001PP
Device Lot Number08103002
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2024
Was Device Evaluated by Manufacturer? Yes
Patient Sequence Number1
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