MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 3; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN922772

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use on a patient, the airway tube detached from the lma cuff.As a result, a 2nd lma was used.No patient harm or injury.The patient status is reported as "fine".Additional information received stated that the patient "desaturated from the high 90s to the low 90s".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that while in use on a patient, the airway tube detached from the lma cuff.As a result, a 2nd lma was used.No patient harm or injury.The patient status is reported as "fine".Additional information received stated that the patient "desaturated from the high 90s to the low 90s".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.Based on review of the photo, the complaint was confirmed.The root cause was determined to be manufacturing related.The manufacturing site has reported that a capa was opened to address the issue.Other remarks: n/a.Corrected data: section d.1.-brand name corrected to lma unique (silicone) cuff pilot 3.Section d.4.-catalog# corrected to 105200-000030.Section d.4.-lot# corrected to qmbqnt.Section d.4.-udi# corrected to (b)(4).

Event Description

It was reported that while in use on a patient, the airway tube detached from the lma cuff.As a result, a 2nd lma was used.No patient harm or injury.The patient status is reported as "fine".Additional information received stated that the patient "desaturated from the high 90s to the low 90s".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 3
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17139835
• MDR Text Key: 317784573
• Report Number: 3011137372-2023-00167
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

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 Expiration Date: 06/28/2023
• Device Model Number: IPN922772
• Device Catalogue Number: 105200-000030
• Device Lot Number: QMBQNT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 07/12/2023; 08/02/2023
• Supplement Dates FDA Received: 07/25/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other