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

Catalog Number	381811
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n autoguard needle did not fully retract.The following information was provided by the initial reporter: 28-may-2025 concern description: doctor attempting to start an iv for a patient, but unable to retract needle from plastic hub.This occurred two times.Psls id(b)(6).No adverse event reported.Customer response received on 12-june-2025.The needle did not fully retract out of the plastic hub.The needle initially began to retract at regular speed and then stopped.Yes the needle started to retract and then stopped.The needle moved and then stopped.Yes the button depressed.
Additional Manufacturer Narrative
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.

• 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: 22293632
• Report Number: 1710034-2025-01053
• Device Sequence Number: 8819660
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2025

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: 4208538
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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