MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NSYTE AUTOGUARD GN 18GA X 1.88IN; PERIPHERAL IV CATHETERS

Catalog Number	381447
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 381447, lot: 4066996.It was reported that the bd nsyte autoguard gn 18ga x 1.88in needle went through the catheter.The following information was provided by the initial reporter: it was reported by customer that when using the bd insyte autoguard 18ga x 1.88 needle under ultrasound guidance, the needle went through the catheter during iv placement rcc received a complaint via email.My name is (b)(6) and i am a nurse at (b)(6) on the rapid response team.Our team assists the vascular access team in placing ultrasound guided iv's.I came across an issue the other week that i wanted to bring to your attention.When using the bd insyte autoguard 18ga x 1.88 needle under ultrasound guidance, the needle went through the catheter during iv placement.From the patient's reaction, the event took place while i was advancing the catheter.Lot: 4066996.Ref: 381447.Exp: 2027-02-28.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle went through the catheter was confirmed and the cause appeared to be associated with use.One photograph was provided for investigation, which showed an 18g insyte autoguard iv catheter with the needle protruding through the side of the catheter tubing.The section of tubing between the catheter tip and the puncture site was filled with what appeared to be blood, which indicates that the tubing was likely damaged during the insertion process.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.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 NSYTE AUTOGUARD GN 18GA X 1.88IN
• 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: 19801617
• Report Number: 1710034-2024-00758
• Device Sequence Number: 20908607
• Product Code: FOZ
• UDI-Device Identifier: 00382903814473
• UDI-Public: (01)00382903814473
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/12/2024

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 Catalogue Number: 381447
• Device Lot Number: 4066996
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown