MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SI CUFF CPV SIZE 5

Catalog Number 105200-000050

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "the markings are coming off during intubation".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer sent six representative samples from the same lot.The samples were sent to the manufacturing site for evaluation.The manufacturing site reports "from review of the 6 (six) samples returned, there was no printing marking comes off or peeled off or sticking on to the film of the pouch" it was also reported that a device history record review was performed and no relevant findings were identified.Without the actual 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.

Event Description

It was reported "the markings are coming off during intubation".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 5
• 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: 12737826
• MDR Text Key: 279581685
• Report Number: 9681900-2021-00032
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318198
• UDI-Public: 15060112318198
• 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: 10/12/2021

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 Expiration Date: 12/28/2023
• Device Catalogue Number: 105200-000050
• Device Lot Number: QMDN5S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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