MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4252527-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in the medsun (b)(4).Describe the event or problem: pt consented for a caudal block prior to chordee correction and circumcision with dr.1 [redacted].After the block timeout and prepping, dr.2 [redacted] started the caudal block with dr.3 [redacted] by her side.Caudal attempted with a 20g catheter.Attempt was unsuccessful and needle with catheter met resistance upon removing.When removing the iv catheter, the needle was fully intact, but 1.5cm of the iv catheter was missing from the catheter pulled out.What was left of the catheter was frayed at the end.Dr.3 [redacted] did an ultrasound in the or and saw the catheter left behind subcutaneously.Care team member reached out to general surgery md.Dr.1 [redacted] spoke with ir [interventional radiology] and placed an order for ultrasound imaging to confirm the location is subcutaneous.Care teams confirmed subcutaneous location of the 1.3cm catheter.Family had been notified that an ultrasound order was placed and went to the front desk concerned.Family placed in consult room for dr.1 [redacted] to inform them of the situation.General surgery md consented the family to remove the catheter.Catheter was a 20g x 1 3/4".Brand: braun.Ref # (b)(4); lot # 24n23g8241 exp date: 12/01/2029.[date redacted] update: cather break.About 1.3cm-1.5cm (both measurements mentioned in notice from rn) remained subcutaneously in patient's lumbar region of back.Upon notification to or management, instructed rn to inform surgeon of need to disclose to family and consider consulting general surgery or ir to visualize catheter for potential removal.Surgeon used ultrasound to attempt to find and remove catheter and upon unsuccessful attempt, consulted ir who successfully removed an approx.1.3cm portion of the distal catheter.Per anesthesia's report to the pt family, dr.2 [redacted] reports "i spoke with parents in pacu [post anesthesia recovery unit] and explained, and demonstrated with a bbraun angiocath, how i think the angiocath fragment was retained subcutaneously at the insertion site in patient's back.I answered all their questions.I reassured them that we are 100% certain that there are no other retained fragments of catheter left." as part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2025-00579, had already been previously submitted timely on 07oct2025.As b.Braun medical, inc.Submitted the manufacturer mdr on behalf of the manufacturer, the importer mdr was inadvertently missed.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 25563575
• Report Number: 2521402-2026-00666
• Device Sequence Number: 18645133
• Product Code: FOZ
• UDI-Device Identifier: 04046963318185
• UDI-Public: (01)04046963318185(11)241223(17)291201(10)24N23G8241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026
• Report Date (Section F): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4252527-02
• Device Lot Number: 24N23G8241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2025
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 MO
• Patient Sex: Male
• Date Report Sent to FDA: 10/07/2025