MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE WITH ACC SIZE 4

Catalog Number 128040

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Airway Obstruction (1699); No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient underwent a surgical procedure on (b)(6) 2020, requiring general anesthesia.The device was successfully inserted by the anesthesiologist and the surgery was completed without issue.At the end of the procedure during patient awakening, the crna in the room attempted to remove the device from the patient.When the crna grasped the airway tube/lma handle and attempted to remove the lma from the patient, the cuff detached from the handle and remained lodged in the patient's throat.This was immediately identified.Patient required propofol and succinylcholine to relax her jaw and the anesthesiologist then fished out the detached cuff using her fingers.All pieces of the device were successfully removed from the patient who recovered well.It was reported the patient was discharged home the next day.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the cuff was detached.The complaint has been confirmed.It was discovered that the air way tube area has glue but the glue is insufficient.There was no lot number was provided to identify the manufacturing date/expiry date.In conclusion, the root cause of the failure was manufacturing related.A non-conformance has been opened to further address this issue.

Event Description

Patient underwent a surgical procedure on (b)(6) 2020, requiring general anesthesia.The device was successfully inserted by the anesthesiologist and the surgery was completed without issue.At the end of the procedure during patient awakening, the crna in the room attempted to remove the device from the patient.When the crna grasped the airway tube/lma handle and attempted to remove the lma from the patient, the cuff detached from the handle and remained lodged in the patient's throat.This was immediately identified.Patient required propofol and succinylcholine to relax her jaw and the anesthesiologist then fished out the detached cuff using her fingers.All pieces of the device were successfully removed from the patient who recovered well.It was reported the patient was discharged home the next day.

• Brand Name: LMA UNIQUE WITH ACC SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9968866
• MDR Text Key: 187949893
• Report Number: 9681900-2020-00004
• Device Sequence Number: 1
• Product Code: CAE
• 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: 03/27/2020

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: No Information
• Device Catalogue Number: 128040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention