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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. VESCO LUER LOCK SYRINGE 10 ML SYRINGE, PISTON

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JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. VESCO LUER LOCK SYRINGE 10 ML SYRINGE, PISTON Back to Search Results
Catalog Number VIV-620EO
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2021
Event Type  malfunction  
Event Description
Vesco medical 20 ml luer lock syringe had particles on the inside of the syringe, they did not move with the solution that was pulled up in the syringe. Upon close examination, the particles were discovered and the medication was discarded. The compounding of the medication was re-started, using a fresh syringe. Fda safety report id # (b)(4).
 
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Brand NameVESCO LUER LOCK SYRINGE 10 ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD.
MDR Report Key12590073
MDR Text Key275877622
Report NumberMW5104453
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVIV-620EO
Device Lot Number20210503
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

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