MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN922892

Device Problem Fracture (1260)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported, that "on (b)(6)2022, a spiderweb cracks [was] found on the tip of the connector before using on patient." no patient involvement reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Clarification was received regarding the event and the issue was discovered post sterilization.There was no patient involvement and the device was not in the clinical setting.Based on this information it was determined that this is not a reportable event; thus, the initial mdr submitted on 05/25/2022 should be retracted.

• Brand Name: LMA PROSEAL SIZE 5
• 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: 14498618
• MDR Text Key: 293312071
• Report Number: 9681900-2022-00015
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318747
• UDI-Public: 15060112318747
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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 Model Number: IPN922892
• Device Catalogue Number: 150050
• Device Lot Number: 8UTAG8HY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1