MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE, REU, SIZE 2.5; LARYNGEAL MASK AIRWAY

Catalog Number 21125

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2016

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 a small elliptical fragment of silicone was found within the lumen during use.There was no patient harm reported.

Manufacturer Narrative

Qn#(b)(4).Correction: brand name - lma flexible, reu, size 2.5.Catalog# - 21125.Device is labeled for single use.Usage of device - initial use of device.Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to the standard operating methods.The root cause of the reported defect was unable to be determined as the defective sample was never received for investigation.However, from the photo that was provided the small elliptical fragment appeared to be the excess material from the aperture bar of the cuff.Relevant operators were made aware of the reported defect and were instructed to be more attentive during production.There will be continued trending of the reported defect.

Event Description

The event is reported as: the customer alleges a small elliptical fragment of silicone was found within the lumen during use.There was no patient harm reported.

• Brand Name: LMA FLEXIBLE, REU, SIZE 2.5
• 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 carringtin mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5772942
• MDR Text Key: 48922691
• Report Number: 9681900-2016-00027
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21125
• Device Lot Number: KDA2JD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• 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