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U.S. Department of Health and Human Services

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

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DPS / DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS BARE HYPODERMIC SYRINGES SYRINGE, PISTON Back to Search Results
Lot Number 2010049
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/05/2021
Event Type  No Answer Provided  
Event Description
[dps needles and syringes] treatment under emergency use. Authorization(eua): we would like to report a critical malfunction with the dps bare hypodermic syringes and safety needles supplied in our pfizer covid-19 vaccine ancillary kits. The needle and syringe combination fails to securely attach and results in the needle detaching from the syringe during vaccine administration. Upon withdrawal, the needle remains lodged in the patient's arm. Not only is this a safety issue, we have lost vaccine doses due to leaking from the hub site.
 
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Brand NameDPS BARE HYPODERMIC SYRINGES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
DPS / DUOPROSS MEDITECH (KUNSHAN) CO., LTD.
MDR Report Key11494659
MDR Text Key240363088
Report NumberMW5099997
Device Sequence Number2
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 03/09/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number2010049
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

Patient Treatment Data
Date Received: 03/15/2021 Patient Sequence Number: 1
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