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

Model Number IPN922772

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device investigation is pending and the results will be submitted in a follow-up report.

Event Description

Reported issue: string of plastic was noticed inside the patient's mouth after the lma was inserted.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened representative sample along with two un-opened representative samples for evaluation.The actual device used in the event was not returned.The manufacturing site reports that the opened sample was visually inspected and did not show the printing trimmed off as reported in the complaint and as seen in the photos provided by the customer.A device history record review was performed on the lot number reported and no relevant findings were identified.The manufacturing site reports "based on the review of the dhr and non-conformance (nc) list, there is no record of printing peeled off or part of airway tube were skimmed/trimmed off.The type of defect is not originated from any of the in house assembly process." 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.

Event Description

Reported issue: string of plastic was noticed inside the patient's mouth after the lma was inserted.No patient injury/consequence or medical intervention reported.The patient condition was reported as "fine".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 4
• Type of Device: 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 ; 9194332672
• MDR Report Key: 16550086
• MDR Text Key: 311581556
• Report Number: 9681900-2023-00008
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN922772
• Device Catalogue Number: 105200-000040
• Device Lot Number: 11F22H0316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED