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

Catalog Number	381811
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n autoguard needle difficult to retract.The following information was provided by the initial reporter: the needle did not retract easily when the retraction button was pushed.Customer responded on (b)(6).1.When you pressed the button, did the needle fully retract? yes, but the button needed to be pressed very firmly.2.Did the needle retract slower than normal? no.3.Did the needle start retracting and then stop, leaving the needle exposed? no.4.Did the needle not move at all after pressing the button? initially yes.It only moved when the button was pressed very firmly.5.Did the button depress? yes, with excess force.
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.
Additional Manufacturer Narrative
Additional information received.Annex e and f codes updated.Device evaluation: bd has confirmed customer complaints for devices with the reported batch, that during insertion of the catheter, the needle is slow to retract or fails to retract.The slow/no retraction may require repeated attempts at retraction of the needle by pressing the button.There is also the potential for a needle to remain exposed, despite shielding attempts.Bd is continuing to investigate the root cause and will take action to prevent recurrence of this issue.
Event or Problem Description
Customer responded on 13-jun."the was no serious harm to the patient or the hcp in this situation.There was minor harm to the patient as multiple iv attempts were required due to the malfunctioning of the device".Patient grid update.

• 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: 22131832
• Report Number: 1710034-2025-00937
• Device Sequence Number: 7356847
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-25-5274
• Patient Sequence Number: 1
• Patient Sex: Unknown