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

Model Number IPN922816

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 319113786
• Report Number: 8040412-2023-00281
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112317979
• UDI-Public: 15060112317979
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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