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

Model Number	383538
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva¿ dual port closed iv catheter system cap separated from the second port during the ct injection.The following information was provided by the initial reporter: "customer is using the nexiva dual port and the cap has popped of the 2nd port the last couple of times that they've use it for ct injection.".
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 the bd nexiva¿ dual port closed iv catheter system cap separated from the second port during the ct injection.The following information was provided by the initial reporter: "customer is using the nexiva dual port and the cap has popped of the 2nd port the last couple of times that they've use it for ct injection.".
Additional Manufacturer Narrative
H6: investigation: our quality engineer inspected the photographs submitted for evaluation.One photo displayed the label of a package from lot #0274618 and another photo displayed a label from an icu medical clave neutral connector.Unfortunately, the photos provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Additional inspections or investigation into the reported defect could not be performed without the physical sample.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text: see h10.

• Brand Name: BD NEXIVA¿ DUAL PORT 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12857110
• Report Number: 1710034-2021-01006
• Device Sequence Number: 17148453
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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): 12/07/2021

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: 09/30/2023
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 0274618
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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