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

Catalog Number	4252519-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported on mw (b)(4): 22g iv catheter broke upon attempted iv removal.The clear catheter portion broke apart from the blue hub.The patient was taken to the ir lab for retained foreign body retrieval.The foreign body was removed completely.Bedside rn removed dressing on rt forearm piv to assess leaking, noted that hub broke off from catheter, and catheter appears to be retained in the body.Rn called vad to assess.Vad asked rn to apply tourniquet to rt upper arm, immediately came to bedside.Pt is calm, no distress.Vad can see catheter fragment on us retained in lower rt forearm cephalic vein; i marked location with sterile skin pen.This vad rn remained at bedside, continuously monitoring pt, kept tourniquet on rt upper arm, applied hand tourniquet to upper forearm, periodically checked that catheter piece remained in same place on us, ensured that pt kept rt arm still/relaxed and did not get out of bed, had pt call her mom so i could update her and ask her to come back to the hospital.Covering mds (intern, fellow, attending) came to bedside to assess and update, state ir team will come in emergently to remove catheter fragment.This vad rn remained at bedside continuously monitoring pt until or was ready, also transporting pt to pre op and given report to ir doctor, until pt wheeled to or room by physicians.Pt remained calm with no distress.As part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2021-00067, had already been previously submitted timely on 09mar2021.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-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 25536938
• Report Number: 2521402-2026-00655
• Device Sequence Number: 9744384
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• 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): 06/17/2026
• Report Date (Section F): 03/09/2021

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: 4252519-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2026
• 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: 13 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/09/2021