MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL INTRODUCER (3, 4 & 5); LARYNGEAL MASK AIRWAY

Catalog Number 151030

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2016

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 the introducer separates when placed into lma prior to use.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.There were two photos provided by the customer.The plastic casing of the sample in the picture was observed transparent and was different from the current retained sample.Therefore the reported complaint cannot be confirmed and the root cause of the failure was unable to be concluded.

Event Description

The event is reported as: the customer alleges the introducer separates when placed into lma prior to use.There was no patient involvement reported.

• Brand Name: LMA PROSEAL INTRODUCER (3, 4 & 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 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5692377
• MDR Text Key: 46323434
• Report Number: 9681900-2016-00018
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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 Catalogue Number: 151030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• 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