MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 2; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175020

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested by teleflex.No additional information received at this time.The device involved has not been received by the manufacturer at the time of this report.The invesigation into this complaint is still in progress.

Event Description

Customer complaint alleges "fixation tap was disconnected".Alleged issue reported as occurred during use.There was no report of patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

(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 although the presence of glue was all around the connector body (joint area between the connector body and the connector plug).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the visual exam, the complaint is confirmed.The root cause is manufacturing related.Corrective action will be taken.

Event Description

Customer complaint alleges "fixation tap was disconnected".Alleged issue reported as occurred during use.There was no report of patient injury or consequence.Patient condition reported as "fine".

• Brand Name: LMA SUPREME, SU, SIZE 2
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7443048
• MDR Text Key: 106042806
• Report Number: 8040412-2018-00104
• 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: 04/02/2018

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: 12/28/2018
• Device Catalogue Number: 175020
• Device Lot Number: KMBPTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1