MAUDE Adverse Event Report: SONTEK MEDICAL, LLC SONTEK SUCTIONAL-SAFE SWIVEL Y

Model Number A1002

Device Problem Connection Problem (2900)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Received a customer complaint from the distributor.During the procedure, the sontek a1002 broke into three parts, and one part blocked the et tube and the patient could not be ventilated.This caused the pediatric patient to collapse hemodynamically.The patient situation was stabilized.The hospital recorded this event as a dangerous incident report (haipro).

Manufacturer Narrative

The firm conducted a postmarket risk assessment and concluded that the risk profile for this failure regarding the swivel y connector is equivalent to or less than the risk profile documented in the original risk management report.Therefore, there is no further action required at this time.The firm will continue its postmarket vigilance for this failure mode and close the file on this event.

Event Description

Received a customer complaint from the distributor.During the procedure, the sontek a1002 broke into three parts, and one part blocked the et tube and the patient could not be ventilated.This caused the pediatric patient to collapse hemodynamically.The patient situation was stabilized.The hospital recorded this event as a dangerous incident report (haipro).

• Brand Name: SONTEK SUCTIONAL-SAFE SWIVEL Y
• Type of Device: SONTEK SUCTIONAL-SAFE SWIVEL Y
• Manufacturer (Section D): SONTEK MEDICAL, LLC; 88 airport drive; rochester NH 03867 1706
• Manufacturer (Section G): SONTEK MEDICAL, LLC; 88 airport drive; rochester NH 03867 1706
• Manufacturer Contact: michael kilday ; 88 airport drive; rochester 03867-1706 ; 6033328900
• MDR Report Key: 17142553
• MDR Text Key: 318016934
• Report Number: 1220018-2023-00001
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A1002
• Device Lot Number: 25929600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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): Required Intervention