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

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.

• Brand Name: 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: HYPODERMIC 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: 6136042
• MDR Text Key: 61146508
• Report Number: 1213809-2016-00041
• 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: 12/14/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• 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