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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 HYPODERMIC SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HYPODERMIC SYRINGE Back to Search Results
Catalog Number 309657
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 11/01/2016
Event Type  Death  
Manufacturer Narrative
Results: a sample is not available for evaluation. A review of the device history records revealed no irregularities during the manufacture of the reported lot # 3121212. 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. Further to add, we again are convinced that the most likely cause is the drug in question and not the bd device used. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Based on the above, situation analysis # (b)(4): has been opened to address this concern. (b)(4).
 
Event Description
It was reported that a 3 ml bd luer-lok disposable syringe with bd luer-lok tip was related to a patient's death. The cause of death was not reported. The relation of the device to the patient¿s unfortunate death is unknown.
 
Manufacturer Narrative
On 11/30/16, (b)(6) stated that although a patient died, his/her death was not related to his/her maintena injection and there was no product quality issue with the kit. The death was reported so that the facility would no longer receive samples.
 
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Brand Name3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
Type of DeviceHYPODERMIC SYRINGE
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 Key6136042
MDR Text Key61146508
Report Number1213809-2016-00041
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,Followup
Report Date 12/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/30/2018
Device Catalogue Number309657
Device Lot Number3121212
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 Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
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: 11/30/2016 Patient Sequence Number: 1
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