MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH SU ETT 7.5MM; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number 112482-000075

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the balloon leaked during intubation and a proper seal could not be made (captured in mdr 9681900-2019-00023).It was reported "they tried to deflate but it was not possible to deflate".The patient desaturated and the tube was removed.The patient was successfully re-intubated with another tube.The patient's condition was reported as "fine".

Event Description

The customer reported the balloon leaked during intubation and a proper seal could not be made (captured in mdr 9681900-2019-00023).It was reported "they tried to deflate but it was not possible to deflate".The patient desaturated and the tube was removed.The patient was successfully re-intubated with another tube.The patient's condition was reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The product code originally reported by the customer was incorrect.The correct product code was identified when the sample was returned and it was discovered that this product is not sold in the us; thus, mdr# 9681900-2019-00024, submitted on 07/25/2019, should be retracted.

• Brand Name: LMA FASTRACH SU ETT 7.5MM
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 8825839
• MDR Text Key: 182596856
• Report Number: 9681900-2019-00024
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• PMA/PMN Number: K051993
• 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: 07/10/2019

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 Catalogue Number: 112482-000075
• Device Lot Number: 18LT04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED