MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INTROSYTE AUTOGUARD 26G; INTRODUCER, CATHETER

Catalog Number	384008
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd introsyte autoguard 26g leaked it was reported by customer that the nurse noticed fluid leading from the hub.Rcc received a complaint via email.I¿m reaching out to share product feedback received from xxx: product name: bd introducer cath introsyte-n picc mdln 1.9fr, 26 gauge reported issue: ¿midline placed in neonate on (b)(6) 2025 @ 2pm.On (b)(6) at 6am the nurse noticed fluid leading from the hub.Line had to be replaced¿.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information received.This mdr is being cancelled due to clarifying information received from the customer.Product confirmed to be not a bd product complaint.
Event or Problem Description
Additional information received.This mdr is being cancelled due to clarifying information received from the customer.Product confirmed to be not a bd product complaint.

• Brand Name: BD INTROSYTE AUTOGUARD 26G
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23720343
• Report Number: 9610847-2025-00445
• Device Sequence Number: 8420988
• Product Code: DYB
• UDI-Device Identifier: 00382903840083
• UDI-Public: (01)00382903840083
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 384008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown