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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. INTROCAN SAFETY INTRODUCER, CATHETER Back to Search Results
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.
 
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Brand NameINTROCAN SAFETY
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th ave
bethlehem PA 18018
MDR Report Key10378360
MDR Text Key202011967
Report Number10378360
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received08/07/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4251890-02
Device Catalogue Number4251890-02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2020
Event Location Hospital
Date Report to Manufacturer08/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2020 Patient Sequence Number: 1
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