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

Catalog Number	382934
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint that the needle would not fully retract was confirmed; however, the root cause could not be determined from the two photographs that were provided for investigation.The photos showed a portion of the insyte autoguard needle extending from the grip component of the safety shield.The barrel component of the safety shield appeared to be damaged, which likely prevented the needle hub from fully retracting.The observable features on the submitted photographs did not contain enough information to identify a specific root cause of the reported event.There were no other similar complaints from the implicated lot.A review of the inspection records and quality and manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended as part of ongoing efforts to identify potential manufacturing related issues.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.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.
Event or Problem Description
It was reported that needles did not fully retract.Yesterday, there were two iv catheters where, when the white button was pressed, the needle did not retract fully into the sheath.Response received on: (b)(6) 2026 "there was no harm done to any person.It was just a shortage that was noticed bij some nurses.".

• 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: 24913795
• Report Number: 1710034-2026-00430
• Device Sequence Number: 9067577
• Product Code: FOZ
• UDI-Device Identifier: 00382903829347
• UDI-Public: (01)00382903829347(11)250923(17)280831(10)5266395
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 382934
• Device Lot Number: 5266395
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown