MAUDE Adverse Event Report: HOBBS MEDICAL, INC. SUPERDIMENSION CYTOLOGY BRUSH

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bronchial Hemorrhage (4456)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

Report received through distributor of several hobbs medical products and other products.Unclear from the report whether or not a hobbs medical device was in fact involved.

Event Description

According to the reporter, during a procedure, the patient was very difficult to intubate due to being fragile post-radiation.After sampling was complete, the physician was suctioning the airways at the end of the procedure and the patient began to bleed.There were approximately 500 millimeters of blood loss and the nurse anesthetist was not able to ventilate.Chest compressions followed, physician gave epinephrine down the bronchoscope and the nurse gave epinephrine intravenously.Ventilation resumed and the patient was sent to the intensive care unit (icu) still intubated.The patient had prolong hospitalization.Report 2 of 2.

• Brand Name: SUPERDIMENSION CYTOLOGY BRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer (Section G): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer Contact: jennifer hodge ; 8 spring street; stafford springs, CT 06076
• MDR Report Key: 17634618
• MDR Text Key: 322093970
• Report Number: 1220592-2023-00006
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Required Intervention; Hospitalization