MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number	IPN902070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "a hole was found on the inflation tube during an inflation test.Therefore, a new unit was opened instead".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed and it was observed that here was hole/tear on the inflation line area.The failure of the inflation line is likely due to touching a hot object.The complaint was confirmed; however, a root cause could not be established.
Event or Problem Description
It was reported that "a hole was found on the inflation tube during an inflation test.Therefore, a new unit was opened instead".No patient involvement reported.

• Brand Name: LMA SUPREME SIZE 3
• Common Device Name: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12053770
• Report Number: 9681900-2021-00018
• Device Sequence Number: 4359201
• Product Code: CAE
• UDI-Device Identifier: 05060112310812
• UDI-Public: 05060112310812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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
• Operator of Device: No Information
• Device Model Number: IPN902070
• Device Catalogue Number: 175030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.