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

Catalog Number	105200-000050
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the markings are coming off during intubation".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported, "the markings are coming off.During intubation".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (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.

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 5
• Common Device Name: 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: 12737893
• Report Number: 9681900-2021-00031
• Device Sequence Number: 4703976
• Product Code: CAE
• UDI-Device Identifier: 15060112318198
• UDI-Public: 15060112318198
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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