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

Model Number	IPN047898
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem 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 or Problem 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".
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 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
• Common Device Name: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11740411
• Report Number: 9681900-2021-00011
• Device Sequence Number: 3673068
• Product Code: CAE
• UDI-Device Identifier: 05060112313868
• UDI-Public: 05060112313868
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUDEL TUBE; GUDEL TUBE