MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN923211

Device Problem Fracture (1260)

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

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "proximal end of the lma cracked.The reported issue was detected prior to use on the patient.There was no patient injury.

Event Description

It was reported that: "proximal end of the lma cracked.The reported issue was detected prior to use on the patient.There was no patient injury.

Manufacturer Narrative

Qn# (b)(4).The actual device was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "dhr was reviewed for this complaint.There was no abnormality found.The complaint sample was observed unloaded from the original product pouch which was not returned along with the sample upon receipt.There were no broken pieces/chips from the connector was returned for evaluation.The connector is made of polypropylene (pp) which is generally known as a strong material, which is a very durable plastic that are resistant to fatigue and has good impact strength.The device passed the necessary final inspection.The actual cause of the incident is classified as undetermined.".

• Brand Name: LMA UNIQUE EVO SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15314349
• MDR Text Key: 305252037
• Report Number: 8040412-2022-00239
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318914
• UDI-Public: 15060112318914
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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 Model Number: IPN923211
• Device Catalogue Number: 1D5040
• Device Lot Number: 11F22C0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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