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

Catalog Number	382623
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K201075; k251654.Our quality engineer inspected the photograph submitted for evaluation.Your report of a leak was confirmed based on the circumstantial evidence that was observed in the photograph that was provided for investigation.The photo showed one 22g insyte autoguard iv catheter with evidence of use.At the tip of the blue adapter, it was noted that blood residue appeared to fill the space between the external surface of the tubing and the internal surface of the adapter.This area was circled with a red overlay on the image.The leak path could not be discerned from the image and the observable features on the submitted photograph as it did not contain enough information to identify a specific root cause of the reported event.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd insyte autog bc wing catheter has a hole in it.We have a lot (#5188475) of 22g catheters that have holes in them.The patient's blood is leaking out of the insertion site, however, the blood control is still in tact.So there's a hole in the tip of the catheters.Customer responded on 17-jun: this has happened on multiple occasions, the first being (b)(6) 2026 at 1000 am.The next was my coworker (b)(6) on (b)(6) 2026, and the last one being (b)(6) 2026 with me again.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.2/3 patients with needle phobia got faint and lightheaded seeing blood run down their arm out of the insertion site.Again, the blood control is intact, but the leak appeared to come from a small hole in the tip of the plastic catheter.

• Brand Name: INSYTE 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: 25682838
• Report Number: 1710034-2026-00751
• Device Sequence Number: 17310982
• Product Code: FOZ
• UDI-Device Identifier: 00382903826230
• UDI-Public: (01)00382903826230(17)280630(10)5188475
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 382623
• Device Lot Number: 5188475
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown