MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE, SU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 125040

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the customer alleges during removal of the device the cuff unattached from the tubing.There is no reported harm to the patient.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed and there was an abnormality detected during production of the reported complaint lot that could lead to the reported defect.A non-conformance ((b)(4)) was issued due to delamination (cuff to backplate) for the process of the cuff and airway tube assembly.The reported complaint cannot be confirmed as the complaint sample was not returned for investigation.If the sample is returned in the future a follow-up report will be submitted.No further action is required at this time.

Event Description

The event is reported as: the customer alleges during removal of the device the cuff unattached from the tubing.There is no reported harm to the patient.

• Brand Name: LMA UNIQUE, SU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• 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: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 6144537
• MDR Text Key: 61450807
• Report Number: 9681900-2016-00052
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 125040
• Device Lot Number: LMBEJM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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