MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SI CUFF CPV SIZE 3

Model Number IPN041107

Device Problem Deflation Problem (1149)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.

Event Description

It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.The sample was functionally tested and it was found that the device could be inflated and deflated with a syringe.No issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 3
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12321137
• MDR Text Key: 266493615
• Report Number: 9681900-2021-00027
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112313578
• UDI-Public: 05060112313578
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/28/2022
• Device Model Number: IPN041107
• Device Catalogue Number: 105200-000030
• Device Lot Number: PRAEKB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• 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