MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ DUAL PORT IV CATHETER WITH Q-SYTE¿; INTRAVASCULAR CATHETER

Catalog Number	383540
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	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 iv catheter with q-syte¿ tubing separated from the adapter after the insertion.The following information was provided by the initial reporter: "after insertion the tubing detached the second blood return.Iv removed.".
Additional Manufacturer Narrative
H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1305458, and no quality issues were found during production.Our quality engineer reviewed the provided photo but could only make out the product label.The provided photo did not show the actual device or the reported defect.Therefore, based off the provided photo the engineer was unable to verify the reported defect.Since the provided photo did not show the actual defect a definitive root cause could not be determined.A physical sample or photo of the actual defect would need to be provided for a more thorough investigation.The manufacturing facility has been notified of this incident and the findings.
Event or Problem Description
It was reported that the bd nexiva¿ dual port iv catheter with q-syte¿ tubing separated from the adapter after the insertion.The following information was provided by the initial reporter: "after insertion the tubing detached the second blood return.Iv removed.".

• Brand Name: BD NEXIVA¿ DUAL PORT IV CATHETER WITH Q-SYTE¿
• 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: 15481583
• Report Number: 1710034-2022-00542
• Device Sequence Number: 5640079
• Product Code: FOZ
• UDI-Device Identifier: 00382903835409
• UDI-Public: (01)00382903835409
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/11/2022

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: 10/31/2024
• Device Catalogue Number: 383540
• Device Lot Number: 1305458
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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