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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS BARE HYPODERMIC SYRINGES 3 ML SYRINGE, PISTON

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DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS BARE HYPODERMIC SYRINGES 3 ML SYRINGE, PISTON Back to Search Results
Catalog Number 100000000171
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
Dps bare hypodermic syringes and dps safety needles treatment under emergency use authorization(eua): the plunger cracked upon drawing up the moderna vaccine; the white hub at the base of the needle was blowing air; when the nurse went to inject the vaccine into the patients left deltoid, the vaccine started leaking out; the hub of the needle was secure on the syringe; since majority of the vaccine was not delivered to patient, a new vaccine syringe was administered to patient in right deltoid; followed cdc guidelines distributed by duopross meditech corp; (b)(6) syringe and needles supplied with the vaccine ancillary kits. Dps bare hypodermic syringe 3 ml lot# unknown; ref 100000000171, dps safety needle 23g x 1 1/2"; lot # unknown; ref 100800000065. Fda safety report id# (b)(4).
 
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Brand NameDPS BARE HYPODERMIC SYRINGES 3 ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
DUOPROSS MEDITECH (KUNSHAN) CO., LTD.
MDR Report Key11655189
MDR Text Key245337245
Report NumberMW5100707
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/09/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100000000171
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?
Type of Device Usage

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