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

Catalog Number	381911
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
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
In the paediatric ward and paediatric intensive care unit, during an attempt at peripheral infusion, the nurse had to use three catheters from this batch.On all three occasions, the needle did not retract (including one occasion where the needle remained bent in the skin).There were no visible consequences on the skin, but this caused pain during catheter insertion, as the procedure had to be repeated several times because the needle would not retract.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a bent needle was confirmed based on the photograph that was provided for investigation.The photograph showed one 24g insyte autoguard device with evidence of use.What appeared to be blood residue was visible within the catheter tubing, catheter adapter, and needle hub.The needle was bent approximately 90-degrees and the overlying catheter conformed to the bend.Due to the evidence of use, the needle likely bent during the insertion process; otherwise, the deformed needle would likely preclude venous access.The photograph showed no evidence that the safety mechanism had been activated; however, the bend in the needle would prevent the deformed section of the needle from fully retracting through the catheter adapter.The unit in the photograph was not returned for investigation; however, sealed representative units and two open 24g insyte autoguard units were provided for investigation.The needles from the opened samples were received fully retracted.A visual observation of the returned samples revealed no damage or defects.None of the needles were bent and a functional test of the returned samples revealed that the needle would fully retract when the safety mechanism was activated and the retraction time was within specification.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.

• Brand Name: INSYTE-N 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: 23729958
• Report Number: 1710034-2025-01899
• Device Sequence Number: 21481249
• Product Code: FOZ
• UDI-Device Identifier: 00382903819119
• UDI-Public: (01)00382903819119(10)5111220
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• 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): 01/29/2026

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: 381911
• Device Lot Number: 5111220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown