MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000040

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint states that during patient use the cuff pilot was stuck and lma would not inflate or deflate.No patient injury or consequence was reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).One lma unique silicone cuff pilot was received for evaluation by the manufacturer.Visual exam of the returned sample revealed no damage observed from the outer profile of the device.The complaint sample was tested using a syringe and the pilot cuff to inflate and deflate the cuff.The device could be inflated and deflated when tested.Customer complaint cannot be confirmed based on this testing.The device functioned as intended.

Event Description

Customer complaint states that during patient use the cuff pilot was stuck and lma would not inflate or deflate.No patient injury or consequence was reported.Patient condition reported as fine.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8395621
• MDR Text Key: 137999184
• Report Number: 3011137372-2019-00062
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 105200-000040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.