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

Catalog Number	381023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
It was reported that catheter broke/separated.It was reported that svh have had to surgically remove the cannula of this product after it was retained.I am still working through the events leading up to this however it's believed it has been retained for about 5 weeks which makes it difficult to ascertain the lot number.14-may-2026 please confirm that the catheter broke off and remained in the patient.Yes.Where on the catheter tubing did the catheter break? did the catheter separate from the adapter, or did it break off somewhere along the catheter tubing length? by measuring it against an intact catheter it appears that it broke at the weld with the hub.What was the catheter being used for at the time of the failure? ivf was a power injector being used? i will double-check this however do not believe so as the patient was a surgical patient under oncology.
Event or Problem Description
25-may-2026 - received an email response from complainant for information.Please confirm that the catheter broke off and remained in the patient.Yes.Where on the catheter tubing did the catheter break? -did the catheter separate from the adapter, or did it break off somewhere along the catheter tubing length? by measuring it against an intact catheter it appears that it broke at the weld with the hub.What was the catheter being used for at the time of the failure? ivf was a power injector being used? i will double-check this however do not believe so as the patient was a surgical patient under oncology.Sabina, are you able to confirm if you have the notes?.
Additional Manufacturer Narrative
Additional information added to b tab investigation results: our quality engineer inspected the sample submitted for evaluation.Your report of a break in the catheter tubing was confirmed; however, the root cause could not be determined.One complete 22g insyte autoguard iv catheter was received taped to an open unit package from lot #5010447.The iv catheter was received without the needle.No breaks were identified in the catheter tubing and the sample did not support the description of the reported event.In addition to the complete iv catheter, a section of iv catheter tubing was also returned for investigation.The sample exhibited evidence of use.One end of the catheter tubing exhibited the tapered manufactured tip.A microscopic examination of the other end of the catheter tubing exhibited an uneven surface, which was consistent with a break or tear.The adjoining end of the catheter tubing and catheter adapter were not provided for investigation.No deformation or features were identified at the break site that would support the confirmation of a manufacturing defect.Without the catheter adapter and remaining catheter segment, it could not be determined how the tubing was damaged.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.

• 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: 25302625
• Report Number: 1710034-2026-00551
• Device Sequence Number: 15782670
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239(11)250113(17)271231(10)5010447
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381023
• Device Lot Number: 5010447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown