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

Catalog Number	383531
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva 24ga 0.75in y catheter was defective/damaged the following information was provided by the initial reporter: during insertion, he noticed that the catheter was cracked.Additional information received on 4-jan-2024 :-patient has been impacted and catheter has been replaced.
Additional Manufacturer Narrative
Current control there is in-process visual inspection for damaged component and outgoing inspection to check for damaged component.Due to no samples and photos were returned for investigation, root cause could not be determined.Complain will be reopened and investigated if sample is received.Manufacture narrative.
Event or Problem Description
During insertion, he noticed that the catheter was cracked.Additional information received on 4-jan-2024 :-patient has been impacted and catheter has been replaced.

• 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 MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18554102
• Report Number: 9610847-2024-00004
• Device Sequence Number: 7587087
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: (01)30382903835318
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102520
• 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,Followup
• Report Date (Section B): 03/13/2024

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: Other
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 383531
• Device Lot Number: 3208656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown