MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 192040

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "it was found before using it to the patient.There was air leaking at the cuff pilot." no patient injury reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.It was found that the device could be inflated and deflated normally.The device was also submerged in water and no air leak was observed.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges "it was found before using it to the patient.There was air leaking at the cuff pilot." no patient injury reported.Patient condition reported as fine.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8006331
• MDR Text Key: 126081392
• Report Number: 9681900-2018-00036
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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: 12/28/2019
• Device Catalogue Number: 192040
• Device Lot Number: LMCBC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.