MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN042498

Device Problem Inflation Problem (1310)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "the cuff of proseal #4 did not inflate when a nurse tried to inflate it after intubation".No patient injury or harm reported.Patient condition reported as "fine".It was reported that device was replaced with a new one.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube was yellowish due to multiple uses.The device was functionally tested and it was able to be inflated and deflated with a syringe.No blockage was found on the red plug, and air inside the device could be released via the red plug.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issued found with the returned device.

Event Description

It was reported that"the cuff of proseal #4 did not inflate when a nurse tried to inflate it after intubation".No patient injury or harm reported.Patient condition reported as "fine".It was reported that device was replaced with a new one.

• Brand Name: LMA PROSEAL SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12738032
• MDR Text Key: 279587883
• Report Number: 9681900-2021-00030
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 04026704319688
• UDI-Public: 04026704319688
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: IPN042498
• Device Catalogue Number: 150040
• Device Lot Number: 8VVAPPW3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1