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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SYRINGE TUBERCU 27GX 1/2 1CC SYRINGE, PISTON

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BD SYRINGE TUBERCU 27GX 1/2 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 05/17/2019
Event Type  malfunction  
Event Description
Pt's husband reports defective syringe. The cap on the syringe was stuck and could not be removed.
 
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Brand NameSYRINGE TUBERCU 27GX 1/2 1CC
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key8640770
MDR Text Key146333659
Report NumberMW5086903
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 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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
Is This a Reprocessed and Reused Single-Use Device?

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