MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175040

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).It was reported that the customer discarded the actual device involved in this complaint.The investigation into this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges "the lma was placed without incident and about two hours later a leak developed.The team attempted to put more air in the device but this failed to stop the egress of air.The lma supreme was removed and at that time it was noted that the bonding between the cuff and device had failed".The reported defect was detected during use.It was reported there was no harm to the patient.The patient's condition was reported as "fine".

Manufacturer Narrative

Qn#(b)(4).A device history record (dhr) was performed and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If a sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges "the lma was placed without incident and about two hours later a leak developed.The team attempted to put more air in the device but this failed to stop the egress of air.The lma supreme was removed and at that time it was noted that the bonding between the cuff and device had failed".The reported defect was detected during use.It was reported there was no harm to the patient.The patient's condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; however, the customer returned a photograph.The photo was evaluated and it was observed that there was glue on the cuff and awt joint area.The failure is a cohesive type of failure (cof).This is a manufacturing related issue.The manufacturer reports that the respective parties were made aware of the incident and respective actions documented in a non-conformance.

Event Description

Customer complaint alleges "the lma was placed without incident and about two hours later a leak developed.The team attempted to put more air in the device but this failed to stop the egress of air.The lma supreme was removed and at that time it was noted that the bonding between the cuff and device had failed".The reported defect was detected during use.It was reported there was no harm to the patient.The patient's condition was reported as "fine".

• Brand Name: LMA SUPREME, SU, SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• 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 ; 9194334854
• MDR Report Key: 6307146
• MDR Text Key: 66771455
• Report Number: 9681900-2017-00006
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

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: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: 175040
• Device Lot Number: LMALYL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2017; 06/29/2017
• 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