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

Catalog Number 309657

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/09/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluation: these are known common side effects of abilify.For death refer to the prescribing information on abilify.Warning and precautions increased mortality in elderly patients with dementia-related psychosis, cerebrovascular adverse events, including stroke, suicidal thoughts and behaviors in children, adolescents, and young adults, seizures/convulsions, suicide, to name a few.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.Otsuka is alerting these manufacturers out of an abundance of caution to ensure that the complaints are being handled with due diligence.Therefore, otsuka has alerted those manufactures listed above to comply with their own policies and procedures.Dhr review for lot implicated show no issues were raised (i.E.Qn/ncmrs).The qn review indicates no quality notifications generated for the batch number involved in these complaints.All release criteria were met, including sterility records.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 a situation analysis has been opened to address this concern.Please refer to situation analysis #: (b)(4).Qn review: a quality notification review indicates no quality notifications generated for the batch number involved in this complaint.The batch #(b)(4) was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review: the result of the device history review indicates that all visual inspections were performed as per requirement with no issues observed during manufacturing process of batch #(b)(4).Complaints received for this product and condition will continue to be tracked and trended.Bd canaan will continue monitoring our manufacturing processes to ensure product quality.

Event Description

The complaint was received with the following verbatim: "on (b)(6) 2016 the call center received the following report, this social worker reports that this male patient who was (b)(6) years old at time of death started abilify (aripiprazole) at unknown dose and frequency on unknown date for schizophrenia, and started abilify maintena (aripiprazole) at unknown monthly dose on (b)(6) 2016 for schizophrenia.The patient's relevant medical history includes hospitalization on (b)(6) 2016, prior to starting abilify or abilify maintena.The patient's relevant concomitant medications include cogentin 2mg daily.The patient's past drug history is unknown.On unknown date oral abilify was stopped.On unknown date last week in 2016 the patient was discharged from the hospital with the next dose of abilify maintena planned for (b)(6) 2016.On (b)(6) 2016 the patient was hit by a car resulting in death.The patient's relevant laboratory data are unknown.As of (b)(6) 2016 the patient no longer takes abilify and no longer takes abilify maintena due to death.The lot number and expiration date are unknown to the reporter.".

• Brand Name: 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: 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 Key: 6001577
• MDR Text Key: 56539393
• Report Number: 1213809-2016-00034
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 309657
• Device Lot Number: 3121212
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 33 YR