MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA NEARPORT 22GA X 1.00IN W/ MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	393522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva nearport 22ga x 1.00in w/ maxzero catheter broke / separated after placement.It was reported by customer that the nexiva nearport 22g x 1¿ iv catheter tubing broke off.Location of the break was at the extension set and the catheter hub.Rcc received a complaint via email.Please accept this email as notification of the following complaint.Xxx.Date of incident: (b)(6) 2026.Product code: 393522.Lot #: unknown.Description of incident: nexiva nearport 22g x 1¿ iv catheter tubing broke off.Location of the break was at the extension set and the catheter hub.There was no patient harm however the device was indwelling at the time of the fracture, and the line had to be removed.Photos are attached to this email, and the customer retained the device and is willing to send to bd for evaluation.Customer is copied on this email.
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 2 photos and 1 physical sample submitted for evaluation.The reported issue of catheter broke / separated after placement was confirmed upon inspection of the samples.Analysis of the sample showed that the photos showed the defect reported by the customer.Evaluation of the physical sample showed the disconnection between the luer and the tube, adhesive on the tube and inside the luer can be observed.When evaluated under magnification, it is possible to see part of the tube inside the luer.Bd was not able to replicate the defect in the manufacturing process or determine the cause of the failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD NEXIVA NEARPORT 22GA X 1.00IN W/ MAXZERO
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24178187
• Report Number: 9610847-2026-00026
• Device Sequence Number: 9486455
• Product Code: FOZ
• UDI-Device Identifier: 00382903935222
• UDI-Public: (01)00382903935222
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K231239
• 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): 03/16/2026

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: 393522
• Device Lot Number: UNKNOWN
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown