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

Model Number	383579
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
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¿ closed iv catheter experienced tubing clamp missing.The following information was provided by the initial reporter: the defective product was removed from a new package ¿ the white clamp was not on the line.It is not that the white clamp had fallen off in any way, it simply was not there to begin with.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-may-2023.H6: investigation summary.It was reported the iv was manufactured without the standard white clamp on the line.To aid in the investigation, one used sample and three photos were provided for evaluation by our quality team.A visual inspection was performed, and the pinch clamp is not present on the device and not observed on the returned unit in the photo.This type of defect is associated with the manufacturing process.A device history record review was completed for provided material number 383579, lot 2186277.The review revealed there were no internal rejects related to the reported issue by the customer.According to the quality records, all the inspections of the sampling plan met the acceptance criteria.Based on the investigation, bd was able to confirm the defect.
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter experienced tubing clamp missing.The following information was provided by the initial reporter: the defective product was removed from a new package the white clamp was not on the line.It is not that the white clamp had fallen off in any way, it simply was not there to begin with.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16820400
• Report Number: 1710034-2023-00449
• Device Sequence Number: 7131776
• Product Code: FOZ
• UDI-Device Identifier: 00382903835799
• UDI-Public: (01)00382903835799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 06/30/2025
• Device Model Number: 383579
• Device Catalogue Number: 383579
• Device Lot Number: 2186277
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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