MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG

Catalog Number 175040

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the mask was tested prior insertion to the patient ok.During use, was impossible to ventilate the patient because the cuff had a air leak.A new device was used , and the surgery went fine.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site in (b)(4) for investigation.The manufacturer reports that during the inflation test the cuff immediately deflated.The sample was submerged in water and a leak was observed on the inflation balloon wall.Under closer observation it was found there were 2 locations on the inflation balloon that were torn.The dhr was reviewed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.Leak testing is performed at the manufacturing site; therefore, a defect of this type would be detected prior to release.

Event Description

It was reported that the mask was tested prior insertion to the patient ok.During use, was impossible to ventilate the patient because the cuff had a air leak.A new device was used , and the surgery went fine.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8061353
• MDR Text Key: 128284664
• Report Number: 9681900-2018-00040
• 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: 11/01/2018

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: 01/28/2021
• Device Catalogue Number: 175040
• Device Lot Number: NMAGVS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1