MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3

Model Number	IPN922816
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "contamination for product appearance found prior to use on patient." no patient involvement.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The sample was returned for investigation.A visual exam was performed and it was observed there was a black loose particle inside the package.A device history record review was performed and no relevant findings were identified.Based on the visual exam the complaint was confirmed.A capa was opened to further investigation this issue.
Event or Problem Description
It was reported that "contamination for product appearance found prior to use on patient." no patient involvement.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 3
• Common Device Name: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17316533
• Report Number: 8040412-2023-00281
• Device Sequence Number: 14470694
• Product Code: CAE
• UDI-Device Identifier: 15060112317979
• UDI-Public: 15060112317979
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: IPN922816
• Device Catalogue Number: 192030
• Device Lot Number: 11F22C0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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