MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN922772

Device Problem Material Separation (1562)

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

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the "lma was inserted in a normal manner.[the doctor] noticed the patient's etc02 levels dropping, attempted to reposition lma.At that point the tube detached from the cuff.[the doctor] was able to reach into the patient's airway and remove the cuff with his fingers.Replaced with another lma.No negative issues with the patient, case continued after this short delay".Additional information received states that there was no patient harm or injury.The patient status is reported as "fine".The user "did not have any indication of damage to the trachea" and that during the event, the patient desaturated to the "low 90's".

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed on the returned device and it was observed that the backplate was detached.It was also found that there was no glue residue on the joint area of the tube.It was also reported that "dhr for the packaging lot 11f22h0075 was reviewed and no abnormalities was found with the complaint lot.No findings or reject on different size of product was observed during the packaging process." the complaint was confirmed based on the visual exam of the returned sample.The root cause is manufacturing related.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the "lma was inserted in a normal manner.[the doctor] noticed the patient's etc02 levels dropping, attempted to reposition lma.At that point the tube detached from the cuff.[the doctor] was able to reach into the patient's airway and remove the cuff with his fingers.Replaced with another lma.No negative issues with the patient, case continued after this short delay".Additional information received states that there was no patient harm or injury.The patient status is reported as "fine".The user "did not have any indication of damage to the trachea" and that during the event, the patient desaturated to the "low 90's".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 4
• 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: 17109744
• MDR Text Key: 317028358
• Report Number: 3011137372-2023-00156
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318181
• UDI-Public: 15060112318181
• 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
• Report Date: 05/23/2023

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 Model Number: IPN922772
• Device Catalogue Number: 105200-000040
• Device Lot Number: 11F22H0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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
• Treatment: N/A.; N/A.