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

Catalog Number	381833
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
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
It was reported that bd insyte autoguard possible iv site infection in the presence of other infectious processes.The following information was provided by the initial reporter, translated from french to english: ¿date of event: (b)(6) 2025, equipment concerned: bd insyte autoguard model: 381833 lot :4310283 per: (b)(6) 2027 problem encountered: after removal of catheter, wound and pain with inflammatory induration of a patient.Action taken: alcohol and water compress on the wound.Atypical treatment, antibiotic.Patient impact: inflammatory pain fever the device is not available photo and doctor's description attached¿ attached is an infection following a peripheral catheter inserted in smr on (b)(6) 2025 at 12 noon before a colonoscopy scheduled for the afternoon.The patient was vomiting and is diabetic.The catheter was removed the same evening after the examination.In the weekend (b)(6) that followed the appearance of pain with inflammatory induration, compress alcohol and water applied.On monday (b)(6) noticed this, patient had covid + fever.Treated by augmentin.No major biological inflammatory syndrome: 36 on (b)(6) and 46 on (b)(6).Apyretic since (b)(6).
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph of an area of the skin appeared to be red and a circle feature in the skin was observed within the area of redness.The iv catheter was not visible in the photograph.No damage or defects associated with the iv catheter could not be confirmed from the image.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing or sterilization process.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 21711035
• Report Number: 1710034-2025-00488
• Device Sequence Number: 10010219
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334(11)241106(17)271031(10)4310283
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 381833
• Device Lot Number: 4310283
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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