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

Catalog Number	381034
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is the result of an investigation finding.Our quality engineer inspected the sample and photographs submitted for evaluation.Your report of a damaged catheter was confirmed and the cause appeared to be manufacturing related.One 20g insyte autoguard iv catheter was returned for investigation.What appeared to be a shaving of catheter material was observed on the external surface of the catheter tubing near the tip.The non-foreign material was likely shaved from the catheter by the needle.The appropriate personnel have been notified.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 determined that bd insyte autog bc global non foreign matter was found during investigation.Original report: "it was reported that the needle had popped out of the catheter before use." "sales rep mentioned that: when they opened the package, the needle was sticking out of the catheter.They have reported this same issue numerous times in the past.Naturally, they did not perform the puncture.".

• 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: 25689283
• Report Number: 1710034-2026-00750
• Device Sequence Number: 21262956
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 381034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown