MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE SIZE 2; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 110020

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reports "pinhole leak in cuff after 19 uses.".No patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and the failure location was identified on the cuff.The device was then immersed in water and air bubbles were observed coming from the hole in the cuff.A device history record review was performed on the lot number of the sample received (8ftaa2t8) and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The device was probably punctured/cut inadvertently due to handling after 19 uses.The lma reusable device should be handled with care.Placing, washing , or autoclaving with items which have hard and sharp edges or points should be avoided because it will have an adverse impact to the silicone material of the cuff and will permanently damage its properties to an irreparable condition.Customer is also reminded that the lma proseal is usable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from date of purchase (whichever is the earlier).

Event Description

Customer reports "pinhole leak in cuff after 19 uses." no patient involvement reported.

• Brand Name: LMA FLEXIBLE SIZE 2
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10728024
• MDR Text Key: 212848686
• Report Number: 9681900-2020-00016
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: 110020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1