MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC, REU, SIZE 4 (100040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 10140

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "air does not enter the mask after the 10th use".Alleged defect reported detected prior to insertion.Another device was obtained for use.No patient harm reported.Patient condition reported as "fine".

Event Description

Customer complaint alleges "air does not enter the mask after the 10th use".Alleged defect reported detected prior to insertion.Another device was obtained for use.No patient harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A brand new retained sample was compared to the returned syringe.On the returned sample, it was observed that the adaptor cap of the check valve was missing.When the device was connected to a syringe, the syringe was unable to blow air into the device or extract air from it.The reported failure was verified.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The brand new retained sample was then sent for simulating the process of connecting with a syringe and disconnecting from it more than 10 cycles.The adaptor cap on the check valve did not detach during the simulation.It was determined that the check valve component was most likely detached/broken due to handling/washing/brushing after multiple cycles of re-use after unpacking.While preparing/washing/brushing the reusable device with tools, they should not come in contact with the check valve.Once the component of the valve is broken/detached, the valve can no longer function normally.

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.

Event Description

Customer complaint alleges "air does not enter the mask after the 10th use".Alleged defect reported detected prior to insertion.Another device was obtained for use.No patient harm reported.Patient condition reported as "fine".

• Brand Name: LMA CLASSIC, REU, SIZE 4 (100040)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8124905
• MDR Text Key: 129068387
• Report Number: 9681900-2018-00041
• 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,Followup
• Report Date: 11/09/2018

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: 02/02/2022
• Device Catalogue Number: 10140
• Device Lot Number: MFAAD9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/19/2018; 01/14/2019
• Supplement Dates FDA Received: 12/19/2018; 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.; NONE REPORTED.