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

Model Number	383530
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date 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 while using bd nexiva¿ closed iv catheter system a label was missing.There was no report of patient impact.The following information was provided by the initial reporter: some packages were also unprinted.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a view of the top web (label) of two unit packages of which one is identified by the print to be of product 24ga bd nexiva closed iv catheter system-dual port, reference number (b)(4), lot number 1109440.The second package is missing the print, therefore confirming the reported defect of label content missing.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system a label was missing.There was no report of patient impact.The following information was provided by the initial reporter: some packages were also unprinted.

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13715640
• Report Number: 1710034-2022-00113
• Device Sequence Number: 17713812
• Product Code: FOZ
• UDI-Device Identifier: 30382903835301
• UDI-Public: 30382903835301
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K102520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 383530
• Device Catalogue Number: 383530
• Device Lot Number: 1109440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown