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

Catalog Number	382512
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle did not retract.While starting an iv so the sonographer can use definity, i gained access to the patients left ac.When i pressed the button for the needle to return into the plastic hull it did not return.The needle was sticking out full length for a good minute until i had to tap the plastic end on the counter for the spring to release so the needle can retract.This caused delay in patient care.This is also a patient and staff safety hazard.Additional information 3/26/2026: it is reported that "this caused a delay in patient care." what occurred with the slow needle retraction that resulted in a delay in care? was there any harm/serious injury as a result of this reported delay? if yes, please describe in detail.The iv malfunction after gaining the iv access was for the sonographer to fully finish their test with the use of definity.Please provide the date of the event.The date that this occurred was 03/10/2026.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The complaint of retraction issues was confirmed and the cause appeared to be manufacturing related.Five representative 24g insyte autoguard units were provided for investigation.A functional test revealed that the needle fully retracted when the safety mechanism was activated; however, the retraction time of one unit exceeded the specification.The appropriate manufacturing personnel were notified of this complaint.A trend has been identified for the reported failure and further actions have been initiated to investigate this type of incident and address the manufacturing root cause.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.
Event or Problem Description
No new 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: 24730001
• Report Number: 1710034-2026-00351
• Device Sequence Number: 18459102
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(17)270930(10)4276449
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 382512
• Device Lot Number: 4276449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown