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	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the insertion of the catheter as part of a ct scan, after the needle and then the catheter had been removed, it was found that the catheter had broken at its distal end.A fragment of the catheter remained in the patient¿s subcutaneous tissue; it was palpable at the puncture site and could not be removed by manual compression.The presence of the foreign body was confirmed by imaging.This incident required medical intervention to remove the fragment.Following this event, the batch in question was immediately withdrawn from use.The medical device in question could not be retrieved from the medical devices functional unit for expert analysis.Response received on mon (b)(6) 2026.Yes, the patient has suffered harm.Whilst the iv was being inserted prior to the ct scan, a section of the catheter broke off and remained in the subcutaneous tissue at the puncture site.This foreign body is palpable and has been confirmed by x-ray imaging.This incident resulted in: physical injury (presence of a subcutaneous foreign body), the need for further investigations (x-ray), additional medical care, including consultation with specialists (radiologists, surgeons/orthopaedic surgeons) and a likely procedure to remove the fragment.
Additional Manufacturer Narrative
Investigation summary: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of catheter broke / separated after placment with lot 5219651 regarding item #381023.Dhr number 5219651 has been reviewed.No related quality issues or process deviations were found during the manufacture of the subassembly lot and packaging line.A review of the applicable risk documents indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional information.
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.

• 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: 24932771
• Report Number: 1710034-2026-00437
• Device Sequence Number: 18808526
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239(11)250807(17)280731(10)5219651
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 5219651
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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