MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR CATHETER

Model Number	383558
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing clamp was missing on the bd nexiva¿ single-port with maxzero¿ needle-free connector.There was no report of patient impact.The following information was provided by the initial reporter: after nexiva was placed, the nurse noticed the pinch clamp was missing.
Additional Manufacturer Narrative
Initial reporter state: address information was not able to be obtained, therefore, (b)(6)was used as a place holder.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 tubing clamp was missing on the bd nexiva¿ single-port with maxzero¿ needle-free connector.There was no report of patient impact.The following information was provided by the initial reporter: after nexiva was placed, the nurse noticed the pinch clamp was missing.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR
• 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: 13654223
• Report Number: 1710034-2022-00102
• Device Sequence Number: 12212712
• Product Code: FOZ
• UDI-Device Identifier: 30382903835585
• UDI-Public: 30382903835585
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/03/2022

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 Model Number: 383558
• Device Catalogue Number: 383558
• Device Lot Number: 1305449
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/22/2022
• 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