MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 24GA 0.75IN Y; INTRAVASCULAR CATHETER

Catalog Number	383531
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd nexiva 24ga 0.75in y needle disengagement (removal) was difficult just to keep you informed that today we came across an issue with an nexiva 24ga cannula (bn 3114096).Upon the cannula going into the patient the nurse was unable to remove the introducer.(metal needle).The cannula was removed and a new cannula with a different batch number was used with no issue.The rest of the cannula's with the same batch number were removed from use.

• Brand Name: BD NEXIVA 24GA 0.75IN Y
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19577210
• Report Number: 2243072-2024-00736
• Device Sequence Number: 15570915
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 383531
• Device Lot Number: 3114096
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown