MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN923488
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that incoming product inspection, a greasy substance was noted on the mask.No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a "black spot observed on product".A device history record review was performed and no relevant findings were identified.The manufacturer conclusion is as follows: "the root cause of the complaint is "undetermined/unknown" as the origin of the debris claimed unable to be determine whether it was from manufacturing site or not as the product was already removed from the pouch.Therefore, the customer complaint report concludes that there is no further escalation or additional action are required.".
Event or Problem Description
It was reported that incoming product inspection, a greasy substance was noted on the mask.No patient involvement.

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 5
• 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: 17292277
• Report Number: 3011137372-2023-00172
• Device Sequence Number: 6658429
• Product Code: CAE
• UDI-Device Identifier: 15060112317924
• UDI-Public: 15060112317924
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 09/27/2025
• Device Model Number: IPN923488
• Device Catalogue Number: 105300-000050
• Device Lot Number: 11F22J0453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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