MAUDE Adverse Event Report: HOBBS MEDICAL, INC. SUPERDIMENSION ASPIRATING NEEDLE

Model Number	SDAN1000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a procedure, the two needles had difficulty deploying, and did not get any tissue sample.It was noted that the nodule characteristics (hard tissue) or were not in the correct spot for deployment.The physician was able to complete the electromagnetic navigational bronchoscopy (enb) portion of the case.However, after the procedure, the patient had pneumothorax.Report 1 of 2.

• Brand Name: SUPERDIMENSION ASPIRATING NEEDLE
• Common Device Name: ASPIRATING NEEDLE
• 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 ; 8606845875
• MDR Report Key: 19011049
• Report Number: 1220592-2024-00001
• Device Sequence Number: 3880140
• Product Code: GAA
• UDI-Device Identifier: 10884521843196
• UDI-Public: (01)10884521843196(17)280501(10)SD0423111
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K860582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: SDAN1000
• Device Catalogue Number: SDAN1000
• Device Lot Number: SD04-23-111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown