MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 192040

Device Problems Break (1069); Crack (1135)

Patient Problem Extubate (2402)

Event Date 12/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investgation into this complaint is in progress at the time of this report.

Event Description

Customer complaint alleges ""it was inserted into a patient and apparently the tip snapped off as the circuit was being connected.The elbow piece of the lma was noted to be broken and cracked.The customer didn't notice this until it was to be connected to the filter and circuit." medical intervention reported "lma was swapped to a new one without the patient being compromised." patient condition reported as "fine".

Event Description

Customer complaint alleges ""it was inserted into a patient and apparently the tip snapped off as the circuit was being connected.The elbow piece of the lma was noted to be broken and cracked.The customer didn't notice this until it was to be connected to the filter and circuit." medical intervention reported "lma was swapped to a new one without the patient being compromised." patient condition reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7224492
• MDR Text Key: 98548185
• Report Number: 9681900-2018-00007
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

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: 05/28/2019
• Device Catalogue Number: 192040
• Device Lot Number: LMA6ZY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILTER AND CIRCUIT; FILTER AND CIRCUIT
• Patient Outcome(s): Required Intervention