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

Model Number IPN923488

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that incoming product inspection, a greasy substance was noted on the mask.No patient involvement.

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 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
• 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
• MDR Report Key: 17292277
• MDR Text Key: 318763249
• Report Number: 3011137372-2023-00172
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112317924
• UDI-Public: 15060112317924
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1