MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC AMT BRIDLE PRO; NASAL TUBE RETAINING SYSTEM

Model Number	4-421618
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Airway Obstruction (1699); Aspiration/Inhalation (1725)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was originally reported to amt on 05/07/2024 by (b)(6) indicating that the retrieval probe was sucked into the patient's airway during bridle placement.The physician was able to remove the device from the patient using forceps.It was reported that this patient was sedated and, on a ventilator, but was able to move their head.It was also reported that the nurse placing the bridle had the probe inserted 2/3 of the way into the nares and that she had a firm grip on it.It is possible the nurse inserted the probe too far into the nasal cavity or at an incorrect angle for the patient's anatomy.If the patient experienced any involuntary head movement during the bridle placement it could contribute to placement issues.It is unclear if the ventilator contributed to the event.While no serious injury occurred, the complaint is being reported to fda due to the unforeseen risk reported from the misplacement of the device.If intervention was not taken to remove the retrieval probe, injury could have occurred.It is believed that the event was caused by device misuse.Examination of the returned device found no manufacturing defects occurred.The probe was found fully intact and functional.Lot information was not available.Amt has logged this complaint into our system for trending purposes under complaint #: (b)(4).
Event or Problem Description
It was reported on 05/07/2024 by (b)(6) of (b)(6) medical center that, "one of our nurses was bridling a cortrak small bore feeding tube and the blue probe with the magnet on it was sucked down into the patient.The patient was on the ventilator, but a chest xray was performed and you can see the magnet from the probe.The md had to go in with forceps and retrieve it".She also noted that, "this is the first time we have seen this.The nurse states she had the probe about 2/3 of the way in and that she had a firm grip on it".

• Brand Name: AMT BRIDLE PRO
• Common Device Name: NASAL TUBE RETAINING SYSTEM
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 19473582
• Report Number: 1526012-2024-00008
• Device Sequence Number: 12530767
• Product Code: KNT
• UDI-Device Identifier: 00842071115890
• UDI-Public: 00842071115890
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142971
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 4-421618
• Device Catalogue Number: 4-421618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown