MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
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 broke / separated after placement we again had an incident with a nexiva catheter, this time with above mentioned reference.Normally my colleague kelly wouters is the account manager of this article, but she is on vacation.Can you tell me what the next steps are? can you give us a brief description of the problem identified? after placing the iv catheter, the patient continued to notice that this catheter hurt a lot.It is a patient for monthly iv administration so she has some experience.Then decided to remove the catheter to place a new one.Part of the catheter remained in the patient, after which surgical removal of the remaining piece was necessary.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issue of catheter broke/ separated after placement was confirmed upon inspection of the sample.Analysis of the sample showed the catheter tubing was broken.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The broken edge of the catheter appeared to have a cutting mark, which indicated that it could have been cut by a sharp object, unrelated to the manufacturing process.It is recommended to follow the instructions for use to not use scissors or other sharp instruments at or near the insertion site.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of catheter broke/ separated after placement was confirmed upon inspection of the photos.It was observed that the nexiva product was used, and the catheter tubing was broken.The broken edge of the catheter appeared smooth in the photo, which indicated that it could have been cut by a sharp object which is not related to the manufacturing process.It is recommended by the instructions for use (ifus) not to use scissors or any other sharp instruments at or near the insertion site.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: NEXIVA
• 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: 22577153
• Report Number: 2243072-2025-00908
• Device Sequence Number: 18506032
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup,Followup
• Report Date (Section B): 08/01/2025

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: 5038755
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 07/31/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown