MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA MADGIC ATOMIZER WITH 3 ML SYRINGE; APPLICATOR (LARYNGO-TRACHEAL),

Model Number	IPN048838
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 315 samples were taken from the current production p/n mad700 madgic atomizer without syringe, lot # 73k2100853, the samples were visually inspected, and issue reported "broken parts - info not provided " was observed in the current manufacturing process.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "that while using a mad600 on a patient, it broke off and fell into their trachea".Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.
Additional Manufacturer Narrative
(b)(4).Additional information received from the customer indicates the patient is "doing well".It was also reported that a "clamp used to remove the atomization device." the customer returned one unit mad600 madgic atomizer with 3 ml syringe for investigation.The syringe was not returned.The returned sample was visually examined with and without magnification.Visual examination of the sample revealed that the device appears used as there is biological material present on the device.No damages were observed to the device.A device history record review was performed and no relevant findings were identified.The sample was sent to the manufacturing site for further evaluation.The manufacturing site was able to confirm that there was no damage to the returned sample.It is possible that the complaint issue relates to the syringe, but this could not be confirmed since the syringe was not returned.Therefore, the root cause of this issue could not be determined.Corrected data: section b.3.-date of event corrected to (b)(6) 2021.
Event or Problem Description
It was reported "that while using a mad600 on a patient, it broke off and fell into their trachea".

• Brand Name: LMA MADGIC ATOMIZER WITH 3 ML SYRINGE
• Common Device Name: APPLICATOR (LARYNGO-TRACHEAL),
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12832170
• Report Number: 3003898360-2021-01035
• Device Sequence Number: 4265395
• Product Code: CCT
• UDI-Device Identifier: 14026704613219
• UDI-Public: 14026704613219
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/10/2022
• Device Model Number: IPN048838
• Device Catalogue Number: MAD600
• Device Lot Number: 73C1900258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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
• Patient Sex: Unknown