MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 5 (150050); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15150

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 "later they found failure on one cuff-valve.They could get air inside the cuff but not out again.Even if they opened the valve and tried to pull air out with a syringe the valve was only working one way to get air inside, not back out." alleged event reported as occurred prior to a patient use during inspection/functional testing.There was no report of patient impact or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube was slightly yellowish due to multiple uses.There was no physical damage found on the outer profile of the device.The device could be inflated and deflated normally with the check valve.The cuff could not be deflated when the red plug was opened.A device history record was performed and there were no issues found that could relate to the reported complaint.The complaint has been confirmed.The opening of the red plug was blocked by the valve hence the cuff could not be deflated even when the red plug was opened.The most probable root cause could have been that excessive force was applied to the valve inside the blue inflation balloon when inflating or deflating the device or over a prolonged period/multiple uses, the valve had gone further into the tubing which resulted in the red plug opening being blocked by the valve.The device is still functional, however, and can still be inflated and deflated normally using the check valve.

Event Description

Customer complaint alleges "later they found failure on one cuff-valve.They could get air inside the cuff but not out again.Even if they opened the valve and tried to pull air out with a syringe the valve was only working one way to get air inside, not back out." alleged event reported as occurred prior to a patient use during inspection/functional testing.There was no report of patient impact or consequence.

• Brand Name: LMA PROSEAL, REU, SIZE 5 (150050)
• 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: 7215016
• MDR Text Key: 98069106
• Report Number: 9681900-2018-00004
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

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: 15150
• Device Lot Number: MFAACB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 02/28/2018
• 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: Initial
• Patient Sequence Number: 1