MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383518
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that two bd nexiva 20 ga x 1-3/4 in single ports were missing the label content.The following information was provided by the initial reporter: "two nexiva catheter packages did not have anything printed on the front when received by customer.The remainder of the box was fine.".
Additional Manufacturer Narrative
Our quality engineer inspected the sample and photographs for evaluation.Bd received two photographs for evaluation.The first photograph showed the top web of two unopened unit packages from the implicated 20g x 1.75¿ nexiva closed iv catheter system.The labeling information was missing from the top web on these two packages.The second photograph showed an unaffected package from a 20g x 1.75¿ nexiva closed iv catheter system and the dispenser box.The unaffected top web contained the relevant printed product information per design.The top web and dispenser box were labeled with ref: (b)(4) and lot: 3180984.A device history record review showed no non-conformances associated with this issue during the production of the reported production batches.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.Customer address added to e tab.
Event or Problem Description
Na.

• Brand Name: BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORT
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18663804
• Report Number: 1710034-2024-00089
• Device Sequence Number: 7128321
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: (01)30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 07/31/2026
• Device Catalogue Number: 383518
• Device Lot Number: 3180984
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown