MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15140

Device Problem Material Separation (1562)

Patient Problem Extubate (2402)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "the end of the tube has snapped off whilst in the patients airway." required medical intervention was to replace the lma.Patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was discolored.Upon closer observation at the failure location, it was observed there were some jagged edges (symptoms of cracks due to force) on the broken connector.The jagged edges at where the connector split appeared to be ruptured by force.The dhr was reviewed and there were no issues found that could relate to the reported complaint.The concentration of detergent and holding time of the autoclaving settings were unknown.A concentrated detergent or overrun holding time could have possibly adversely impacted the sturdiness of the connector when external force was applied.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be established.

Event Description

Customer complaint alleges "the end of the tube has snapped off whilst in the patients airway." required medical intervention was to replace the lma.Patient condition was reported as "fine".

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• 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: 7130746
• MDR Text Key: 96020686
• Report Number: 9681900-2017-00048
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/05/2017

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: 15140
• Device Lot Number: 8VRA2Q56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention