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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI SOL-LILLENNIUM MEDICAL PRODUCTS CO, LTD. SOL-MILLENNIUM 5 CC SYRINGE LUER LOCK SYRINGE, PISTON

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SHANGHAI SOL-LILLENNIUM MEDICAL PRODUCTS CO, LTD. SOL-MILLENNIUM 5 CC SYRINGE LUER LOCK SYRINGE, PISTON Back to Search Results
Model Number 1852110T
Device Problems Contamination (1120); Crack (1135); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
A 5cc syringe had a hairline crack along the barrel causing leakage and contamination of the radiopharmaceutical. The integrity and sterility of the product was compromised. (b)(4).
 
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Brand NameSOL-MILLENNIUM 5 CC SYRINGE LUER LOCK
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
SHANGHAI SOL-LILLENNIUM MEDICAL PRODUCTS CO, LTD.
shanghai, xuhui district
CH
MDR Report Key9202673
MDR Text Key162853020
Report NumberMW5090432
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1852110T
Device Catalogue Number1852110T
Device Lot Number18090412
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/16/2019 Patient Sequence Number: 1
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