MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. Insyte AUTOGUARD; Peripheral IV Catheters

Catalog Number	38184414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd insyte autoguard catheter broke and portion was retained.Patient (b)(6), admitted on (b)(6) 2026, to the uco unit, bed 28, developed delirium during hospitalization, presenting with psychomotor agitation and loss of peripheral venous access via a 18 mds jelco catheter.Following the incident, the tip of the jelco catheter was found to be retained in the right upper limb (mds).The cardiovascular surgery (ccv) team was called in to attempt its removal, but the procedure was unsuccessful.
Additional Manufacturer Narrative
E1.All customer demographic information on the regulatory document states "confidential".G.4.K201075; k251654 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 INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50873049
• Report Number: 9610048-2026-00159
• Device Sequence Number: 10715254
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)260114(17)281231(10)5356320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 38184414
• Device Lot Number: 5356320
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown