MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381511
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
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
Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.[no patient harm reported].Description of issue: piv 24g 0.56in placed to r ac.Iv successful, but plastic at end of hub was cracked/chipped.Unable to connect syringe or saline lock to iv hub, so had to pull piv.Pt had blood glucose of 19 at time of iv placement.Oral sucrose given per md while reattempting piv placement.
Additional Manufacturer Narrative
The complaint of a damaged catheter adapter was confirmed, and the cause appeared to be manufacturing related.One 24g insyte autoguard iv catheter was returned for investigation.The threaded end of the catheter adapter was missing material, which appeared to have broken away.Damage to the catheter adapter can occur during assembly or part transfer due to machine misalignment.No other similar complaints were reported from the implicated lot.The appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No new information.

• Brand Name: INSYTE-N AUTOGUARD
• 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: 23539349
• Report Number: 1710034-2025-01750
• Device Sequence Number: 9683067
• Product Code: FOZ
• UDI-Device Identifier: 00382903815111
• UDI-Public: (01)00382903815111(11)250415(17)280331(10)5097606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 381511
• Device Lot Number: 5097606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown