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

Catalog Number	381811
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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
It was reported that bd insyte-n autoguard needle defect causes mechanism to stick.The following information was provided by the initial reporter: once the catheter was in the vein, and blood return was confirmed, the catheter was advanced in the vein as normal.Up to this stage everything was fine.The issues have arrived at the moment the nurses needed to retrieve the needle by pushing on the white push button to retract the needle.The needle stays stuck on the little white part of the push button so when the thought they securely retracted the needle and pulled to retrieve, everything came out, needle and cannula(catheter) when installing the jelco, when removing the needle, the mechanism gets stuck and the catheter follows with the needle.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle was getting stuck during retraction could not be confirmed from the three shielded needles that were provided for investigation.Each needle was received fully retracted within the safety shield.The iv catheters were not returned with the needles.A functional test showed that each needle fully retracted when the safety mechanism was activated.No damage or defects associated with the manufacturing process could be identified on the returned samples.Although the returned samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD 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: 21997197
• Report Number: 1710034-2025-00803
• Device Sequence Number: 21185244
• Product Code: FOZ
• UDI-Device Identifier: 00382903818112
• UDI-Public: (01)00382903818112(11)240731(17)270731(10)4208538
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201075
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 381811
• Device Lot Number: 4208538
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown