MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922772
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that as the doctor "was placing the lma in the patient's airway, the silicone cuff came apart from the plastic tube and then got lodged in the patient's airway.The doctor was able to pull it out safely".Additional information states that there was no patient harm or injury, the patient status is reported as "fine".The procedure was completed with minimal delay and the patient did not experience any oxygen desaturation.The device was brand new with no noticeable damages.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed on the returned device and it was observed that the backplate was detached.The presence of glue was noticed on the joint area of the tube and the backplate joint area.It was also reported that "dhr for the packaging lot 11f22k0418 was reviewed and no abnormalities was found with the complaint lot.No findings or reject on different size of product was observed during the packaging process." the complaint was confirmed based on the visual exam of the returned sample.The root cause is manufacturing related.
Event or Problem Description
It was reported that as the doctor "was placing the lma in the patient's airway, the silicone cuff came apart from the plastic tube and then got lodged in the patient's airway.The doctor was able to pull it out safely".Additional information states that there was no patient harm or injury, the patient status is reported as "fine".The procedure was completed with minimal delay and the patient did not experience any oxygen desaturation.The device was brand new with no noticeable damages.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17109975
• Report Number: 3011137372-2023-00159
• Device Sequence Number: 13996607
• Product Code: CAE
• UDI-Device Identifier: 15060112318181
• UDI-Public: 15060112318181
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Model Number: IPN922772
• Device Catalogue Number: 105200-000040
• Device Lot Number: 11F22K0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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