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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE TUBERCU 27GX1/2 1CC SYRINGE, PISTON

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BECTON DICKINSON SYRINGE TUBERCU 27GX1/2 1CC SYRINGE, PISTON Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  Injury  
Event Description
The patient stated she was having difficulty removing the cap off the syringes. She was wanting to know if insulin syringes could be used in place of it. I told her that would be okay but to make sure the syringe could hold the total volume (1ml). She stated she would have to use pliers to remove the needle cap. I advised her to try the syringes we are sending first.
 
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Brand NameSYRINGE TUBERCU 27GX1/2 1CC
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key9995058
MDR Text Key189142955
Report NumberMW5094248
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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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