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

Catalog Number	381512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nsyte autoguard winged catheter tip integrity issue.The following information was provided by the initial reporter: with the new subs for the iv catheters lyn has had the needle go through the small sheath on two different devices.It may have been cracked as she did not pull the needle back and reinsert.Not sure if this has been reported from any other areas but we wanted to get that to supply chain to make sure it was recognized.I talked to amber she said the catheter sheared on two separate iv's with the same rn how was the patient outcome? are there any clinical signs, health consequences or impact? both patients needed second attempt at iv.Any adverse event or serious injury reported to patient or health care professional? no.
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.E1.Address information was not provided, therefore, xx was used as a place holder.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 381512 and lot number 3292288.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD NSYTE AUTOGUARD WINGED
• 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: 18972036
• Report Number: 1710034-2024-00230
• Device Sequence Number: 15006020
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 09/30/2026
• Device Catalogue Number: 381512
• Device Lot Number: 3292288
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown