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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION DPS BARE HYPODERMIC SYRINGE 1ML SYRINGE, PISTON

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DUOPROSS MEDITECH CORPORATION DPS BARE HYPODERMIC SYRINGE 1ML SYRINGE, PISTON Back to Search Results
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 03/19/2021
Event Type  malfunction  
Event Description
Per report from staff at site, when a student nurse was attempting to inject a second dose of moderna covid vaccine, the syringe came apart and the dose was wasted. Given reports of prior issues with the haiou syringe, i would like to report this syringe in case there have been other incidents: needle and syringe information: mckesson 25g x1" needle, dps bare hypodermic syringe 1ml. This event was also reported on vaers and to the covid call center. Fda safety report id # (b)(4).
 
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Brand NameDPS BARE HYPODERMIC SYRINGE 1ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
DUOPROSS MEDITECH CORPORATION
MDR Report Key11581134
MDR Text Key242986985
Report NumberMW5100312
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

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