MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT, 20G X 1.75"; INTRAVASCULAR CATHETER

Model Number	383518
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 the bd nexiva single port, 20g x 1.75" tubing was defective.The following information was provided by the initial reporter: customer reported external tubing split in half while injecting ct contrast (isovue 370) at a rate of 1.9ml/sec.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a used 20g nexiva unit.The extension tubing appears discolored, and a long tear can be on the extension tubing close to the catheter adapter end.Based on these observations, it is likely that the tubing ballooned and burst during infusion.No kinks can be seen on the unit; however, the full unit is not visible, so it still remains a potential root cause.During manufacturing, a ballooned tubing may result from an occlusion due to excess adhesive between the catheter adapter and extension tubing or from kinked tubing.If an occlusion was present, the components would have to be partially occluded as a full occlusion would likely cause the clinician to experience issues during flashback and flushing of the device.Additionally, during use, ballooning may occur due to a kinked, occluded, or obstructed tubing.Without the physical device the root cause could not be further narrowed down.A device history record review showed no non-conformances associated with this issue during the production of this batch.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.
Event or Problem Description
It was reported that the bd nexiva single port, 20g x 1.75" tubing was defective.The following information was provided by the initial reporter: customer reported external tubing split in half while injecting ct contrast (isovue 370) at a rate of 1.9ml/sec.

• Brand Name: BD NEXIVA SINGLE PORT, 20G X 1.75"
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17358102
• Report Number: 1710034-2023-00816
• Device Sequence Number: 20468991
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: (01)30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 10/31/2025
• Device Model Number: 383518
• Device Catalogue Number: 383518
• Device Lot Number: 2300204
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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