MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Date of incident: (b)(6) 2025 concern description: internal cannula broke off in patient when anesthesia flushed iv site.
Additional Manufacturer Narrative
Customer clarified patient impact.Record updated.Evaluation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Was the catheter breakage confirmed through diagnostic evaluation? yes.If yes, what diagnostic method or test was used to verify the presence of the catheter fragment? the anesthesiologist completed an ultrasound examination which confirmed ¿hyperechoic structure approx.10-15 mm in length within left forearm vein¿, the cannula remained in the patient.What procedure or technique was employed to remove the catheter fragment from the patient? a cutdown was performed to remove the cannula.

• Brand Name: NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23908248
• Report Number: 1710034-2025-01990
• Device Sequence Number: 21338245
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: (01)00382903835126
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 383512
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown