MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000050

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been returned to the manufacturer.However, the investigation of said device is still in progress at the time of this report.A follow-up report will be filed at the conclusion of the device investigation.

Event Description

Customer complaint alleges "there is a loose shaving of pvc in the tube part of the lma." alleged issue reported as detected prior to use on patient (pre-testing).No report of patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that there was flashing inside the airway tube.The complaint has been confirmed.A capa was opened to address this issue.

Event Description

Customer complaint alleges "there is a loose shaving of pvc in the tube part of the lma." alleged issue reported as detected prior to use on patient (pre-testing).No report of patient injury or consequence.Patient condition reported as "fine".

• Brand Name: LMA UNIQUE SILICONE CUFF PILOT, SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7297062
• MDR Text Key: 101021877
• Report Number: 3011137372-2018-00062
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

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: No Information
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 105200-000050
• Device Lot Number: MQAE69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1