MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 5; LARYNGEAL MASK AIRWAY

Catalog Number 15150

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The complaint is reported as: "hole in inner tube when opened".There was no report of patient injury or harm.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the device was yellow in color.It was also observed that there was a hole in the drain tube in the orifice area of the cuff.Under closer observation, there were signs of a puncture/cut on the drain tube.The cut was approximately 2 mm long.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.It is most likely that the cuff was punctured/cut inadvertently during handling.Lma devices should be handled with care.They are made of soft material and should be kept away from any objects with sharp and hard points.

Event Description

The complaint is reported as: "hole in inner tube when opened".There was no report of patient injury or harm.

• Brand Name: LMA PROSEAL, REU, SIZE 5
• Type of Device: LARYNGEAL MASK AIRWAY
• 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: 6490053
• MDR Text Key: 72796624
• Report Number: 9681900-2017-00023
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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: 15150
• Device Lot Number: 8JRAFFX3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1