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

Catalog Number	383518
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr reportable determined as a part of an investigation finding.The complaint of complications when retracting the needle through the tip shield was confirmed and the cause appeared to be related to the washer through which the needle passes during disengagement.The inner diameter of the washer was found to be below specification.No other similar complaints were reported from this lot.The appropriate manufacturing personnel were notified of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that bd nexiva needle was difficult to disengage from the catheter.The following information was provided by the initial reporter: event description: i attempted to start an iv on a pt and when trying to loosen the connections on the catheter, i noticed that it was significantly more difficult that it usually is.Had i started the iv on the pt without checking.I would have not been able to retract the needle without potentially causing harm on the pt.This is the 3rd catheter i have come across with issue in the last month, just the first i was able to save to report.Response received on 12-sep-2023: 1.It was mentioned that this has happened for the 3rd time.Are you able to provide the date of incident for the other 2 incidents? - unfortunately, at this time i do not know the other 2 dates of incidents.2.Was the procedure completed as planned? - yes, to the best of my knowledge, they completed it with a different catheter.3.Please confirm if there was any adverse event or serious injury being reported? - near miss.4.Was there any patient involvement for the previous incident? if yes, what was the outcome? - unfortunately, we do not know the involvement.

• Brand Name: BD 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: 18204874
• Report Number: 1710034-2023-01339
• Device Sequence Number: 6414758
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: (01)30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102520
• 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
• Report Date (Section B): 11/06/2023

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 383518
• Device Lot Number: 2306261
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown