MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4

Catalog Number 192040

Device Problems Inflation Problem (1310); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if a sample device is available for investigation.

Event Description

The complaint was reported as "lma could not be inflated/blocked".The customer reported "the defect occurred during use, i.E.Immediately after the installation of the lma the cuff could not be inflated.It was very obvious that the spiral in the "cuff-pilot" stucked and could not be loosened by inflation, means the cuff could not be inflated." the cuff was not tested prior to use.There was no patient injury, but it was reported ventilation was interrupted.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the outer profile of the device was standard and normal.Functional testing was performed and the cuff could be inflated and deflated with no issues.Leak testing was also performed and no leakage was found.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The complaint was reported as "lma could not be inflated/blocked".The customer reported "the defect occurred during use, i.E.Immediately after the installation of the lma the cuff could not be inflated.It was very obvious that the spiral in the "cuff-pilot" stucked and could not be loosened by inflation, means the cuff could not be inflated." the cuff was not tested prior to use.There was no patient injury, but it was reported ventilation was interrupted.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Type of Device: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8889590
• MDR Text Key: 182599964
• Report Number: 9681900-2019-00035
• 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: 07/29/2019

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: 09/28/2019
• Device Catalogue Number: 192040
• Device Lot Number: LMBRQW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED