MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	383531
Medical Device Problem Codes	Break (1069); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd nexiva 24ga 0.75in y catheter broke / separated after placement verbatim: ¿on removal of canula, plastic catheter found to be missing.? broken off inside patient.During use.During routine canula management, leakage noted from canula.On removal it was noted that the plastic catheter which sits inside the vein was missing from the canula.Patient had to have investigations to see if it remained in the vein.Investigations did not show the cateter in the patient but nursing staff remained convinced that it wasn't there on removal.Unfortunately, the canula was not saved for inspection.¿.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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.Current control there is in-process visual inspection for damage component and outgoing inspection in place to check for functionality of the product ie; retraction test, flashback, catheter adapter pull test.The nexiva manufacturing process was reviewed, there is no change in process that can cause the catheter tubing damage / defective.
Additional Manufacturer Narrative
Corrections made to annex a code and annex f code.See updated in grids.
Event or Problem Description
Corrections to annex a and f codes required.

• Brand Name: NEXIVA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 22328952
• Report Number: 2243072-2025-00789
• Device Sequence Number: 12837185
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(11)250212(17)280131(10)5027675
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383531
• Device Lot Number: 5027675
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025; Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/24/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown