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

Model Number	383538
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a popping noise was found during use with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter, "when attempting to stick a patient there is like a pop where the needle pushes back inside the catheter lumen.".
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that a popping noise was found during use with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter."when attempting to stick a patient there is like a pop where the needle pushes back inside the catheter lumen.".

• 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: 9819344
• Report Number: 1710034-2020-00165
• Device Sequence Number: 2415877
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 9325212
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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