MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number IPN922900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The complaint sample was received at the manufacturing site for evaluation.Prior to review of the sample there was no infected tag on the complaint sample.The product pouch was attached.The lot number and size were same as the complaint description.Proper investigation cannot be performed as the device still inside the complaint packaging and no infected tag to confirm the product has been disinfected.From the outer package reviewed, the complaint description of "cuff separated from tube during use" is confirmed as the part was observed as separated (cuff and airway tube).The device history for the packaging lot 11f22do273 was reviewed and found no abnormalities with the complaint lot.The device history review for the assembly process lot affected was reviewed and there was no nonconformances issued for the assembly lot.It was concluded that the complaint root cause is undetermined/unknown.Further investigation will be completed after clarity of the complaint sample status is obtained from complaint handling coordinator and a follow-up report will be submitted when the sample investigation is completed.

Event Description

Reported issue: patient was under general anesthesia for a urological procedure.When waking up, the nurse was removing the laryngeal mask and at the same time the patient clenched his teeth and the tube separated from the cuff.The inurse had to extract the cuff manually.

Manufacturer Narrative

(b)(4).The complaint sample was received and a visual inspection was performed on the product.The lot number and the size was the same as the complaint description.After verifying the product the actual defect was the airway tube was detached from the backplate.The inflation line also was detached from the cuff.On visual inspection of the airway tube and backplate it was observed that the awt-backplate joint area, showed the airway tube area has glue mark on the airway tube.In the device history review for the packaging lot 11f22do273 no abnormalities were found.In the device history review for the assembly process for the affected lot no nonconformance were issued.Since there was the presence of glue on the airway tube area and airway tube was detached due to patient clenching his teeth the root cause identifies as undetermined/unknown.There was limited information related to how the patient clenched the part or how doctor/user remove the device.In conclusion, based on the complaint description of "cuff separated from tube during use", reviewing of the device history of the packaging and assembly lot, there was no abnormality found.After reviewing the sample received, the defect was the same as the complaint description, the airway tube was detached from the backplate.Since there was glue marking present on the airway tube area and the airway tube was detached due to the patient clenching his teeth, the root cause identifies as undetermined/unknown.

Event Description

Reported issue: patient was under general anesthesia for a urological procedure.When waking up, the nurse was removing the laryngeal mask and at the same time the patient clenched his teeth and the tube separated from the cuff.The inurse had to extract the cuff manually.

• Brand Name: LMA UNIQUE SIZE 4
• Type of Device: LMA UNIQUE
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16491714
• MDR Text Key: 311252970
• Report Number: 9681900-2023-00007
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318259
• UDI-Public: 15060112318259
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN922900
• Device Catalogue Number: 125040
• Device Lot Number: 11F22D0273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Outcome(s): Required Intervention