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

Catalog Number	383531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
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 needle retraction failure the following information was provided by the initial reporter: upon inserting the cannula inside the patient's vien i tried to remove the metal needle but it wont budge, and removed the entire cannula for safety reasons because the needle part is broken and wont budge.During insertion and during removal the metal needle wont budge, and needle was broken and would not budge.
Additional Manufacturer Narrative
Current control there is in-process functional test and outgoing inspection in place to check for retraction and incorrect assembly (premature decouple, decouple failure, tip shield failure, crimp check).From the returned photo, it is observed that the nexiva needle assembly is attached to the part.As there is no abnormality during the production run and outgoing process and no samples were returned for investigation, root cause could not be determined.The complaint will be re-opened and re-investigated if sample is returned.
Event or Problem Description
Upon inserting the cannula inside the patient's vien i tried to remove the metal needle but it wont budge, and removed the entire cannula for safety reasons because the needle part is broken and wont budge.During insertion and during removal the metal needle wont budge, and needle was broken and would not budge.

• 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: 18489184
• Report Number: 2243072-2023-02295
• Device Sequence Number: 3665414
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: (01)30382903835318
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K102520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/25/2024
• 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