MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY; INTRODUCER, CATHETER

Model Number 4251890-02

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Cardiopulmonary Arrest (1765); Ventricular Fibrillation (2130); Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

The patient was brought to the operating room and laid supine on the operating table.After adequate general anesthesia was obtained, the right shoulder was prepped and draped in the usual sterile fashion.A small incision was made and a large amount of purulent material was then evacuated.There does appear to be extension down to the shoulder joint just on manual palpation with the suction device.Fluid was sent for culture.At this point, the patient went into cardiac arrest with ventricular fibrillation.Acls protocol was initiated with eventual return of spontaneous pulses as well as respirations; however, i did not place a drain.I merely quickly closed the small incision due to the ongoing need for chest compressions and resuscitation.The patient was taken to the icu in critical condition.During the resuscitation of the patient on the aforementioned incident, the b.Braun medical inc.Introcan fep straight safety® iv catheter 14 ga.X 1.25 in.Broke inside the patient's av fistula where the hub meets the catheter shaft.The broken end was not retrieved at the time due to the patient's critical condition.It is presumed that it migrated to the pulmonary vasculature.

• Brand Name: INTROCAN SAFETY
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 10378360
• MDR Text Key: 202011967
• Report Number: 10378360
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251890-02
• Device Catalogue Number: 4251890-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21170 DA