MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE, SU, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 125050

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested by teleflex.Customer confirmed that the defect was noticed by the anaesthesia nurse during the preparation of the material for anaesthesia.Patient was not injured.The device has been returned to the manufacturer.However the investigation of said device is still in progress at the time of this report.

Event Description

Customer complaint alleges "the tube contains a loose plastic part." usage of the device at the time the alleged defect was detected was reported as unknown.There was no report of patient involvement.There was no report of patient or user injury.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was a loose plastic part inside the airway tube.The dhr was reviewed and found high defect trending of excess glue at the back plate.All the affected products were scrapped during production.Based on the visual exam, the reported complaint was confirmed.The loose plastic part was excess cure glue.The root cause is listed as manufacturing related.A non-conformance was opened to address this issue.

Event Description

Customer complaint alleges ""the tube contains a loose plastic part." usage of the device at the time the alleged defect was detected was reported as unknown.There was no report of patient involvement.There was no report of patient or user injury.

• Brand Name: LMA UNIQUE, SU, SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7215755
• MDR Text Key: 98194725
• Report Number: 9681900-2018-00005
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: Health Professional
• Device Catalogue Number: 125050
• Device Lot Number: MMA95K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1