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

Catalog Number	381912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Necrosis (1971); Swelling/ Edema (4577)
Date of Event	03/24/2026
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
Event details: it was reported that kt inserted in a&e at 14:30; insertion verified and correct; then, at 15:00 in paediatrics, it was observed that the antibiotic was leaking subcutaneously whilst the kt was still securely in place.This incident has occurred at least six times in recent weeks.Clinical consequences for the patient and the user: following the migration, induration of the arm developed, with even a suspicion of early necrosis.Application of a g30 dressing.Concerns among healthcare staff regarding this recurring issue and the disposal of products in the waste bin or even breaking them due to fear of these recurring migration phenomena response received on thu 3/26/2026 could you confirm whether the six incidents involved the same batch number (5149276) or whether several batch numbers were involved? if several batches are involved, please provide all the batch numbers.No, unfortunately, the batch could only be identified in 1 of the 6 incidents for each of the six incidents, did a patient or user suffer harm? if so, please describe the nature and extent of the harm for each incident.We do not have details of the harm suffered either, but in all cases, oedema was observed, or even induration with leathery skin extending up to the shoulder, with the onset of necrosis on the hand.And the team was kept busy every hour monitoring and changing dressings in g30, measuring the arm to monitor progression.Could you confirm whether the six incidents occurred on the same day or on different dates? if they occurred on different dates, please state the exact dates of each incident.We do not have the exact dates, but these six incidents were observed over the last six weeks.Could you confirm the total number of patients affected by these six incidents? 6 patients in the event of a leak, please specify the type of fluid that leaked.Antibiotic therapy, g5 hydration.
Additional Manufacturer Narrative
Investigation summary: root cause couldn't be determined due to unavailability of sample information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.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.

• 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: 24866345
• Report Number: 1710034-2026-00413
• Device Sequence Number: 13079342
• Product Code: FOZ
• UDI-Device Identifier: 00382903819126
• UDI-Public: (01)00382903819126
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 381912
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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