MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4

Model Number IPN047898

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Airway Obstruction (1699)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported ""the insertion of the lma protector was difficult, the anaesthesia was deepened, the lma protector was removed from the mouth and a gudel tube was inserted for a light mask ventilation.During the insertion of the guedel tube, a foreign part was discovered in the patient's throat.This part, a small plastic ring was removed out of the patient's throat.This ring is usually at the tip of the lma tube".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported ""the insertion of the lma protector was difficult, the anaesthesia was deepened, the lma protector was removed from the mouth and a gudel tube was inserted for a light mask ventilation.During the insertion of the guedel tube, a foreign part was discovered in the patient's throat.This part, a small plastic ring was removed out of the patient's throat.This ring is usually at the tip of the lma tube".No patient injury or harm reported.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 and it was observed that the small plastic ring (seen in a photo provided by the customer) that was reported detached from the lma protector was not returned along with the sample.The manufacturer also reports "both areas (backplate distal end and drain tube to backplate gluing area) have the presence of the glue on the jointing area.There was no clear evidence that an excess glue was detached from both area.Furthermore, the foreign part (small plastic ring) as per complaint description was not available with complaint sample to further investigate and match to identify which location the foreign material origin from." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint was confirmed; however, a root cause could not be established.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Type of Device: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11740411
• MDR Text Key: 257239281
• Report Number: 9681900-2021-00011
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112313868
• UDI-Public: 05060112313868
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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: No Information
• Device Expiration Date: 12/28/2022
• Device Model Number: IPN047898
• Device Catalogue Number: 192040
• Device Lot Number: PMDFZB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUDEL TUBE; GUDEL TUBE