MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number IPN901799

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bronchospasm (2598)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "dr.(b)(6) was removing the unique size, 4, at the end of the procedure, as she pulled the lma out, she felt some mild resistance, the lma was pulled, and she then realized that the airway tube had separated from the cuff.Patient then experienced some bronchospasm, and began to desaturate.She was then forced to paralyze the patient, was then successful in removing the rest of the lma.Patient then experienced no further issues".Patient condition reported as "fine".

Event Description

It was reported "dr.Vora was removing the unique size, 4, at the end of the procedure, as she pulled the lma out, she felt some mild resistance, the lma was pulled, and she then realized that the the airway tube had separated from the cuff.Patient then experienced some bronchospasm, and began to desaturate.She was then forced to paralyze the patient, was then successful in removing the rest of the lma.Patient then experienced no further issues".Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed on the returned device and it was observed that the backplate joint showed that the airway tube had glue; however, the glue was insufficient.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.The root cause of the failure is manufacturing related.A non-conformance has been opened to address this issue.

• Brand Name: LMA UNIQUE SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12260160
• MDR Text Key: 264531655
• Report Number: 9681900-2021-00023
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112310317
• UDI-Public: 05060112310317
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: IPN901799
• Device Catalogue Number: 125040
• Device Lot Number: QMBHTP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention