MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383538
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with tubing separation.It was stated ¿at time of insertion of this piv, when flushing the integrated intension tubing was not fully connected at point of entry.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: device/batch history record review could not be performed as the lot number was not provided.Observations and testing could not be performed because units were not received for investigation of this incident.Conclusions: the defect tubing defective/damaged; as stated as the reported code could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
Event or Problem Description
It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with tubing separation.It was stated ¿at time of insertion of this piv, when flushing the integrated intension tubing was not fully connected at point of entry.¿ there was no report of injury or further medical intervention.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7570731
• Report Number: 1710034-2018-00270
• Device Sequence Number: 13897003
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383538
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other