MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1.5

Catalog Number 175015

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the device broke in the patient's mouth during intubation.The device did not separate into two pieces, as the gastric tube was connecting it.It was reported the patient was bagged while a new device was prepared and intubated.No patient injury reported.Patient condition was reported as "fine".

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the connector plug was detached from the connector body.A device history record review was performed and no relevant findings were identified.Based on the visual exam the reported complaint was confirmed.The root cause was determined to be manufacturing related.A non-conformance was opened to address this issue.

Event Description

Customer reported the device broke in the patient's mouth during intubation.The device did not separate into two pieces, as the gastric tube was connecting it.It was reported the patient was bagged while a new device was prepared and intubated.No patient injury reported.Patient condition was reported as "fine".

• Brand Name: LMA SUPREME SIZE 1.5
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9279472
• MDR Text Key: 183107808
• Report Number: 9681900-2019-00047
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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: 12/28/2019
• Device Catalogue Number: 175015
• Device Lot Number: LMCA2N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED