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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD 30ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY (BD) BD 30ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Catalog Number 305618
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2020
Event Type  malfunction  
Event Description
Bd luer-lok tip 30 ml syringes observed to have leaking of compounded sterile product around the tip of the plunger. 265 30ml syringes were leaking and were discarded. Fda safety report id # (b)(4).
 
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Brand NameBD 30ML SYRINGE, LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
franklin lakes NJ 07417
MDR Report Key10483137
MDR Text Key205532686
Report NumberMW5096387
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number305618
Device Lot Number0065656
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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