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	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 was slow to retract.The following information was provided by the initial reporter: based on customer feedback, bd has determined that when inserting the catheter, the needle retracts slowly or does not retract at all.Slow or no retraction may result in repeated attempts to retract the needle by pressing the button.It is also possible that a needle may remain exposed despite attempts to cover it.
Additional Manufacturer Narrative
Investigation results: 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.Please see attached customer notification urgent: medical device recall (removal) mds-25-5274 - bd insyte¿ autoguard¿ and please take the actions as identified in the notification.Bd is committed to advancing the world of health.Our primary objectives are patient and user safety and providing you with quality products.We apologize for any inconvenience this issue may have caused you and thank you in advance for helping us to resolve this matter as quickly and effectively as possible.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Correction: cancel mdr.Clarifying information received: on 1-jul-25: complaint to be cancelled.Not a complaint from a customer.The sales rep only shares the recent field action mds_25_5274 as it suspected complaint was related to this fsca.Intake team erroneously created 3 new complaints based on the bd field action document.
Event or Problem Description
Clarifying information received: on 1-jul-25: complaint to be cancelled.Not a complaint from a customer.The sales rep only shares the recent field action mds_25_5274 as it suspected complaint was related to this fsca.Intake team erroneously created 3 new complaints based on the bd field action document.

• 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: 22196118
• Report Number: 1710034-2025-00985
• Device Sequence Number: 9275026
• 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: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/29/2025; 07/03/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/30/2025; 07/07/2025
• 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