MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA PROSEAL, REU, SIZE 3 (150030); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15130

Device Problem Air Leak (1008)

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

Event Date 07/28/2017

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 "a nurse found an air leak from the cuff while conducting inspection before using it to a patient at operating room." there was no report of patient harm or delay in treatment.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The record card returned with the device indicates 17 uses.A visual exam was performed and it was observed that the airway of the tube was lightly discolored and it was verified that the cuff would not hold air when inflated.When the device was immersed in water, it was observed that there were air bubbles coming from the cuff.Upon closer observation, it was found that there was a cut on the surface of the cuff.The length of the cut was approximately 1mm.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 was determined that the device was punctured/cut inadvertently during handling by the customer.Placing, washing, or autoclaving the device with items that have a hard or sharp edge/point should be avoided as it will have an adverse impact to the silicone material of the cuff and will permanently damage it.

Event Description

Customer complaint alleges " a nurse found an air leak from the cuff while conducting inspection before using it to a patient at operating room." there was no report of patient harm or delay in treatment.

• Brand Name: LMA PROSEAL, REU, SIZE 3 (150030)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): THE LARYNGEAL MASK COMPANY; singapore
• 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: 6908452
• MDR Text Key: 88063708
• Report Number: 9681900-2017-00037
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

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: Health Professional
• Device Catalogue Number: 15130
• Device Lot Number: 8WQADCLZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 10/25/2017
• 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