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

Catalog Number	381811
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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 catheter released prematurely.The following information was provided by the initial reporter translated from spanish to english: the chief of service proceeds to perform the cannulation with safety catheter # 24.With security catheter # 24 for which performs review of the device which is fractured separating the needle from the grip of the catheter probe reason for which cannot be used and is performed change it.Additional information received on 09 apr 2025.Has there been any harm to patients/healthcare professionals? no.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received three photographs which displayed a 24gx.56in unit from lot #3333219.Your report that the iv catheter separated from the needle was confirmed; however, the root cause could not be determined.The needle was present, but was fully retracted within the shield.The yellow catheter adapter was positioned within the needle cover and appeared to be misoriented, which likely caused it to become lodged within the needle cover.As the device had been opened, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.There were no distinguishing features which could aid in identification of a specific root cause.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 21905394
• Report Number: 1710034-2025-00661
• Device Sequence Number: 21014762
• Product Code: FOZ
• UDI-Device Identifier: 00382903818112
• UDI-Public: (01)00382903818112
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 3333219
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown