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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON

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BECTON DICKINSON SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON Back to Search Results
Lot Number 1056610
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Indication: myositis, sicca syndrome [sjogren]; event: spontaneous; patient reported leakage out of 3 syringes with reference number 1056610, expiration: 02/28/2026. No missed dose; no ade reported; unknown if available for return. No further information known. Used to infuse hizentra at: hizentra 20% (10gm total) 0. 2gm/ml infuse 12gm (60ml) subcutaneously every week. Hizentra 20%(2gm total) 0. 2gm/ml infuse 12gm (60ml) subcutaneously every week. Reported to (b)(6) by pt/caregiver.
 
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Brand NameSYRINGE 50ML L/L NO NEEDLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12481606
MDR Text Key272443177
Report NumberMW5104020
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/21/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1056610
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

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