MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number	IPN901799
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bronchospasm (2598)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem 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 or Problem 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".
Additional 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
• Common Device Name: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12260160
• Report Number: 9681900-2021-00023
• Device Sequence Number: 20045569
• Product Code: CAE
• UDI-Device Identifier: 05060112310317
• UDI-Public: 05060112310317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention