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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 Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 08/09/2016
Event Type  Death  
Manufacturer Narrative
Date of death: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. Results: a sample is not available for evaluation. A review of the device history record 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. Otsuka ability maintena is sold in kits. Each kit contains product from several other manufactures, (b)(4). 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. Based on the above, a situation analysis has been opened to address this concern. (b)(4).
 
Event Description
A report from a customer was received with the following information: "on an unknown date after starting abilify maintena, the patient passed away. No cause of death was reported and the product (or components) were not specifically implicated. No additional information is known. There is no complaint sample or photographs available. " no additional information was received and the relationship of the suspect device to the patient death is unknown.
 
Manufacturer Narrative
An expiration date for lot # 3121212 was provided on 10/5/2016. Medical device expiration date: 4/30/2018.
 
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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 Key5880271
MDR Text Key52272114
Report Number1213809-2016-00027
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 10/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2016
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 Received08/09/2016
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: 08/16/2016 Patient Sequence Number: 1
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