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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE 3 ML SYRINGE WITH NEEDLE

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SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD. DUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE 3 ML SYRINGE WITH NEEDLE Back to Search Results
Device Problems Detachment Of Device Component (1104); Contamination (1120)
Patient Problem Injury (2348)
Event Type  No Answer Provided  
Event Description
Hospital reported that while injecting a radiopharmaceutical, the needle became detached from the syringe. This caused the healthcare worker to contaminate himself with the radioactive material, contaminate the patient and contaminate the injection area. The healthcare worker reported the same thing happened earlier in the week but he did not report that incident.
 
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Brand NameDUOPROSS 3 ML SYRINGE WITH 21G 1" NEEDLE
Type of Device3 ML SYRINGE WITH NEEDLE
Manufacturer (Section D)
SHANGHAI MISAWA MEDICAL INDUSTRY CO. LTD.
shanghai
CH
MDR Report Key6518657
MDR Text Key73604050
Report NumberMW5069275
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

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