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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

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BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP Back to Search Results
Catalog Number 309657
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/20/2016
Event Type  Death  
Manufacturer Narrative
Two potential lot numbers were provided for this incident. The information for these lot numbers is as follows: medical device lot #: 3121212, medical device expiration date: 4/30/2018, device manufacture date: 05/01/2013. Medical device lot #: 5022712, medical device expiration date: 01/31/2020, device manufacture date: 01/22/2015. Results: a sample is not available for evaluation. A review of the device history records revealed no irregularities during the manufacture of the potential reported lot numbers 3121212 and 5022712. Conclusion: without a sample, an absolute root cause for this incident cannot be determined. Additionally, our quality engineer notes that otsuka ability maintena is sold in kits. Each kit contains product from several other manufactures, wajiki, baxter, smiths, west and bd. It was noted in conversations with otsuka that at no time were any individual components or the product in general directly implicated in the patient's death. It is highly unlikely that the device in question lead to the patient's unfortunate death. (b)(4).
 
Event Description
It was reported that a (b)(6) male died of heat stroke. The relation of the device to the patient's death is unknown.
 
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Brand Name3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
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 Key6001535
MDR Text Key56536267
Report Number1213809-2016-00031
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number309657
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/05/2016 Patient Sequence Number: 1
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