MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383517
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 20 ga x 1-1/4 in single port adapter / connector defective / damaged during use, the needle cone cannot be retrieved.The number of affected products is (b)($).Samples can be returned, and photos are available.No claim is necessary, but the return and exchange process must be followed.A complaint response letter and complaint receipt letter are required.It has been confirmed with the escalation that the affected number is 60 the faults are: 1.Screw on the heparin cap and the individual indwelling needle will crack 2.Unable to withdraw the needle core.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and 55 samples submitted for evaluation.The reported issues of needle disengagement difficult and adapter/ connector defective/ damaged were not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.Samples were able to be fully retracted and the cannula outer diameter was measured and found within specification.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 root cause could not be determined as the defect was not replicated.

• 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: 22567142
• Report Number: 2243072-2025-00898
• Device Sequence Number: 17119665
• Product Code: FOZ
• UDI-Device Identifier: 00382903835171
• UDI-Public: (01)00382903835171(11)250316(17)280229(10)5071133
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 383517
• Device Lot Number: 5071133
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown