MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000030

Device Problems Deflation Problem (1149); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is in progress.

Event Description

Customer complaint alleges the "crna pulled the product to prep for case.Upon removing from packaging she attempted to fully deflate but was unable to remove air from the cuff.The cuff pilot would not allow air to be added or removed".Alleged malfunction reported as prior to use on patient (pre-testing).Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The device was manufactured according to release specification.The sample was returned for evaluation.The sample was sent to the supplier for evaluation.The supplier reports that the sample was tested with two different syringes and the cuff was able to be inflated and deflated.The supplier reports that to properly inflate and deflate the cuff push the syringe into the outer cylinder with strength, then rotate the syringe about 45.Air can then be inflated or deflated from the cuff.Based on the investigation performed the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges the "crna pulled the product to prep for case.Upon removing from packaging she attempted to fully deflate but was unable to remove air from the cuff.The cuff pilot would not allow air to be added or removed".Alleged malfunction reported as prior to use on patient (pre-testing).Patient condition reported as "fine".

• Brand Name: LMA UNIQUE SILICONE CUFF PILOT, SIZE 3
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6540355
• MDR Text Key: 74317573
• Report Number: 3011137372-2017-00173
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

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 Expiration Date: 11/01/2019
• Device Catalogue Number: 105200-000030
• Device Lot Number: LQAFNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1