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

Model Number	IPN923211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8040412-2022-00239
• Device Sequence Number: 17522304
• Product Code: CAE
• UDI-Device Identifier: 15060112318914
• UDI-Public: 15060112318914
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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