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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD 3 ML SYRINGE LUER-LOK TIP SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY BD 3 ML SYRINGE LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Catalog Number 309657
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2021
Event Type  malfunction  
Event Description
Iv levothyroxine (in bd 3ml iv syringe) infusing via medfusion syringe pump noted to be leaking fluid from pump about halfway through infusion (total dose volume
=
1. 9 ml). Infusion paused and remainder of med pushed through med tubing (bd maxzero ref mz9267) and when 3 ml syringe (bd ref 309657, lot 0198091, bud 6/30/2025) attached to med tubing to flush medication through, there was leaking noted at the clave on the end of the med tubing. 10 ml ns flush syringe noted to not have any leaking. Bd 3 ml iv syringes (ref 309657) were tested with bd maxzero extension set tubing (ref mz9267) and noted leaking at the connector only for bd syringe lot 0198091. Other 2 lot # of 3 ml bd iv syringes did not leak with the tubing. Bd iv 5 ml syringes did not leak with tubing nor did monoject 3 ml iv syringes. This also occurred in (b)(6) 2019 when bd 3 ml iv syringes (ref 309657, lot 8255627) caused leaking with microbore extension set tubing. In (b)(6) 2019 only this lot number caused leaking. This event will also be reported to bd. Fda safety report id # (b)(4).
 
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Brand NameBD 3 ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
MDR Report Key11462063
MDR Text Key239486833
Report NumberMW5099911
Device Sequence Number1
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 03/03/2021
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309657
Device Lot Number0198091
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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