MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SI CUFF CPV SIZE 4

Catalog Number 105200-000040

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the o-ring on the manometer became stuck in the red zone.The device could not inflate or deflate and was pulled from the patient.No patient injury was reported.Patient conditon was reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.Upon visual inspection it was discovered that only the inflation line was returned.The inflation line was connected to a syringe.When the syringe moved, the manometer also moved.Testing by the manufacturer was performed on a retained sample.It was able to be inflated and deflated normally.No issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the sample returned, the complaint could not be confirmed.The entire sample is needed to perform a proper investigation and to determine a root cause.

Event Description

Customer reported the o-ring on the manometer became stuck in the red zone.The device could not inflate or deflate and was pulled from the patient.No patient injury was reported.Patient condition was reported as "fine".

• Brand Name: LMA UNIQUE SI CUFF CPV SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9347701
• MDR Text Key: 189882600
• Report Number: 3011137372-2019-00392
• 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: 10/30/2019

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 Expiration Date: 03/28/2022
• Device Catalogue Number: 105200-000040
• Device Lot Number: PRACLB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.