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

Catalog Number	382544
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "during placement of iv catheter, flashback obtained and when attempting to advance catheter, the tip broke off and was lodged inside the pt's arm".Additional information 2/19/2026: date of occurrence was (b)(6) 2026.Yes, there was resistance when trying to advance the catheter after getting flashback site was very painful/tender for patient and piece of catheter was palpable at the site, no other symptoms noted the provider attempted to extract the retained tip using sterile procedure with a scalpel and sterile instruments but was unsuccessful.We attempted to use us to locate the retained tip, but this was also unsuccessful.The provider consulted general surgery, but i'm not sure what the follow-up was with that.From my understanding, the following night the patient reported that the pain improved and nothing else was done, but i am not 100% sure.Correct, it was the tip of the plastic catheter.Needle was completely intact.
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
No new information.
Additional Manufacturer Narrative
The complaint of a damaged catheter was confirmed; however, the root cause could not be determined.One 18g insyte autoguard device was returned for investigation.A microscopic examination revealed a slit in the catheter tubing at the tip.The iv catheter was noted to be intact, and no part of the catheter tubing appeared to be missing.The overall length of the iv catheter was within specification, and the formed tip appeared to be complete.The cause of the slit could not be determined.Due to the evidence of use, it could not be determined with certainty whether the damage originated during manufacturing or during the insertion process.There were no similar complaints for the implicated lot.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.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.Complaints received about 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 data collected 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: 24448067
• Report Number: 1710034-2026-00189
• Device Sequence Number: 10307944
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: (01)00382903825448(17)280831(10)5261114
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 382544
• Device Lot Number: 5261114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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