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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. FIXED NEEDLE INSULIN SYRINGE SYRINGE, PISTON

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SMITHS MEDICAL ASD, INC. FIXED NEEDLE INSULIN SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2019
Event Type  malfunction  
Event Description
Rn removed insulin syringe from packaging and noticed that there was an extra needle attached to the syringe on the side. Insulin syringe discarded by bedside rn but packaging sequestered with extra needle.
 
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Brand NameFIXED NEEDLE INSULIN SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
MDR Report Key9103342
MDR Text Key159602650
Report Number9103342
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2019
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? Yes
Date Report Sent to FDA08/28/2019
Event Location Hospital
Date Report to Manufacturer09/23/2019
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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