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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED HYPODERMIC SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED HYPODERMIC SYRINGE Back to Search Results
Catalog Number 305780
Device Problems Material Separation (1562); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during use a bd eclipse¿ bd luer-lok¿ syringe with detachable needle malfunctioned as ¿when a user pulled a syringe's plunger top, it separated from the plunger seal. There was no report of exposure, injury or medical intervention needed.
 
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Brand NameECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
Type of DeviceSAFETY ENGINEERED HYPODERMIC SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7349127
MDR Text Key103007618
Report Number8041187-2018-00071
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305780
Device Lot Number7293229
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/19/2018 Patient Sequence Number: 1
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