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 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.

• 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: 5880271
• MDR Text Key: 52272114
• Report Number: 1213809-2016-00027
• 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,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• 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: 82 YR