MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383551
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 24 ga x 0.75in sp with maxzero needle retraction failed it was reported by the customer that flashback noted but unable to advance therefore removed.Upon removal, it was noticed that the needle did not retract all the way and had punctured the catheter.Verbatim: rcc received a complaint via email.Email(s) attached.Iv inserted.Flashback noted but unable to advance therefore removed.Upon removal, it was noticed that the needle did not retract all the way and had punctured the catheter.Item - 383551 lot - 5136556.
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
Our quality engineer inspected the photo submitted for evaluation.The reported issues of difficulty advancing slider and needle retraction were not confirmed upon inspection of the photo.However, it was observed that the cannula had pierced through the catheter tubing.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and sample submitted for evaluation.The reported issues of difficulty advancing slider and needle retraction failure were confirmed upon inspection of the sample.Analysis of the sample showed that the cannula had a bend and had pierced through the catheter.An activation test was performed on the sample, and it was observed that the sample could not be fully activated due to the needle bend.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.

• Brand Name: NEXIVA MAXZERO
• 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: 23979870
• Report Number: 2243072-2025-01562
• Device Sequence Number: 10717030
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: (01)00382903835515(11)250520(17)280430(10)5136556
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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 Catalogue Number: 383551
• Device Lot Number: 5136556
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 02/03/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/21/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown