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

Model Number IPN922773

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.

Event Description

Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.

Manufacturer Narrative

(b)(4).All complaints are trended across product families on a monthly basis.The dhr for the packaging lot 11f22e0212 was reviewed and found no abnormalities with the complaint lot.Dhr for the assembly process lot affected was reviewed and there were no nonconformances issued.Assembly dhr for inflation line to cuff pilot valve used was reviewed and there was no issue with the cpv lot for the final assembly product.Based on the review of the dhr and nonconformance list there is not issue of product cannot be deflated were found related with the finished packaging or assembly product lot.The investigation shall be reissued or carried out once the complaint sample is returned to kulim plant.Therefore, the current root cause of the product, unable to be deflated, is concluded as "undetermined/unknown".Further investigation shall be performed once the complaint sample is returned to kulim.

• Brand Name: LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16018182
• MDR Text Key: 308126332
• Report Number: 3011137372-2022-00246
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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: IPN922773
• Device Catalogue Number: 105200-000050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Required Intervention