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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD. DPS (DUOPROSS) SYRINGE WITH NEEDLE 3 ML SYRINGE WITH 22G 1" NEEDLE

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SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD. DPS (DUOPROSS) SYRINGE WITH NEEDLE 3 ML SYRINGE WITH 22G 1" NEEDLE Back to Search Results
Lot Number 20150103
Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Other  
Event Description
Three syringes were involved from this lot: there was a hair-like filament, 3/4" in length, found in the newly opened package. The needle tip was blunt instead of tapered. There was a fiber on the needle.
 
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Brand NameDPS (DUOPROSS) SYRINGE WITH NEEDLE
Type of Device3 ML SYRINGE WITH 22G 1" NEEDLE
Manufacturer (Section D)
SHANGHAI MISAWA MEDICAL INDUSTRY CO., LTD.
shanghai
CH
MDR Report Key5410221
MDR Text Key37529681
Report NumberMW5060007
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 Received02/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number20150103
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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