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

Catalog Number	383518
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd nexiva single port, 20g x 1.75" the tubing had expanded.There was no report of patient impact.The following information was provided by the initial reporter: this morning (b)(6) 2022 the nurse found the bd nexiva, insert at the arm of the patient.The extension was upblowed (diameter of extension in one part larger then the normal extension diameter.So the nurse removed the bd nexiva and informed the administration/shopping department.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 04-nov-2022.H6: investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received two units of the nexiva device for the investigation of this complaint.Upon inspection of the received devices, one unit was sealed in the packaged and did not have any physical damage.The second unit was a catheter assembly containing an extension tubing that had expanded near the port.The diameter of the extension tubing on the used device was expanded near the luer adapter and the wall thickness of the tubing had thinned, which can occur if the pressure within the device exceeds the recommended pressure.The reported issue was confirmed.Per the ifu(instructions for use), the maximum power injector pressure limit is 300psi.If this pressure limit is exceeded, ballooning is likely to occur.Additionally, a ballooned tubing may occur due to the tubing being kinked or occluded during pressure injection.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 single port, 20g x 1.75" the tubing had expanded.There was no report of patient impact.The following information was provided by the initial reporter: this morning ((b)(6) 2022) the nurse found the bd nexiva, insert at the arm of the patient.The extension was upblowed (diameter of extension in one part larger then the normal extension diameter.So the nurse removed the bd nexiva and informed the administration/shopping department.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15748560
• Report Number: 1710034-2022-00661
• Device Sequence Number: 19579096
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: 00382903835188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/09/2022

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: 05/31/2024
• Device Catalogue Number: 383518
• Device Lot Number: 1147974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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