MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 150030

Device Problem Break (1069)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: "15mm connector of [the device] snapped off just before insert it to patient." no patient involvement reported.

Manufacturer Narrative

(b)(4).The device was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports: "the complaint sample was received.The device looks yellowish due to multiple uses.A usage record card was returned along with the sample and it was found that the serial number on the device does not match with the one printed on the usage record card; the actual number of uses of the device could not be verified based on it." it was also reported that "the connector of the sample was observed broken upon receipt; the rest of the broken part of the connector was not returned for investigation.On closer observation, there were some jagged edges (symptoms of cracks due to force) on the broken connectors at the failure location.The jagged edges at where the connector split appeared to be ruptured by force." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the root cause of the issue is deemed user handling related.

Event Description

It was reported that: "15mm connector of [the device] snapped off just before insert it to patient." no patient involvement reported.

• Brand Name: LMA PROSEAL SIZE 3
• 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 ; 9193614124
• MDR Report Key: 14842966
• MDR Text Key: 296615887
• Report Number: 9681900-2022-00024
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 01506011238723
• UDI-Public: 1506011238723
• 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: 06/16/2022

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 Catalogue Number: 150030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1