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

Catalog Number	383538
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva catheter separated.The following information was provided by the initial reporter: i had a very unfortunate event happen to a pt yesterday who was coming in a sensitive issue the nurses poked her 2 times then called us.I successfully placed a 20 g 1.75 went to flush it and noticed blood running down her arm.I took the dressing off and noted that the iv tubing was completely separated form wings of the catheter.Yes, an adverse event happened.Pt had previously been poked 2 times before they called us.I successfully placed a 20 g 1.75 went to flush it and noticed blood running down her arm.I took the dressing off and noted that the iv tubing was completely separated form wings of the catheter.The patient was extremely upset that not only had she been poked now 3 times, but we needed to poke her again.
Additional Manufacturer Narrative
In response to the event reported by your facility, a device history review was conducted for lot number 4276209.Our records show that this is the only instance of this issue occurring in this production batch.Six nexiva units were received for evaluation, five of which were sealed and one unsealed.Visual inspection of the sealed units confirmed proper adhesive bonding between the extension tubing and catheter adapter, with no damage or defects observed.The unsealed unit exhibited evidence of use and was received with the extension tubing completely separated from the adapter.No signs of cutting or tampering were observed, and uv light inspection revealed insufficient adhesive at the bonding site.Based on the results of this investigation, the reported complaint of tubing separation was confirmed and determined to be manufacturing-related.To prevent future occurrences of this event our engineers have issued a notification to the appropriate personnel of this occurrence.
Event or Problem Description
No new information,.

• 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: 22777946
• Report Number: 1710034-2025-01327
• Device Sequence Number: 9167031
• Product Code: FOZ
• UDI-Device Identifier: 00382903835386
• UDI-Public: (01)00382903835386(11)241029(17)271031(10)4276209
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 383538
• Device Lot Number: 4276209
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown