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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE COMBINATION SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE COMBINATION SYRINGE AND NEEDLE Back to Search Results
Catalog Number 309571
Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
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 the needle of the bd luer-lok¿ syringe with precisionglide¿ needle combination separated during use and broke off when she was administering her husbands monthly dosage. No reported injury or medical intervention noted to her husband. Found during use.
 
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Brand NameBD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE COMBINATION
Type of DeviceSYRINGE AND NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7647225
MDR Text Key112852855
Report Number1213809-2018-00388
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Catalogue Number309571
Device Lot Number7093988
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 Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2017
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: 06/28/2018 Patient Sequence Number: 1
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