MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15140

Device Problem Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is in progress.

Event Description

Customer complaint alleges "prior to use noticed connector absent.Sheared off." usage of the device at the time of the reported event is unclear.There was no report of patient harm.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the device was discolored.It was also noticed that there were some jagged edges (symptoms of cracks due to force) on the broken connector.The jagged edges where the connector split appeared to be ruptured by force.Based on the investigation performed, the reported complaint was confirmed.The type of detergent used, concentration of detergent, and autoclaving settings were unknown.A non-compatible detergent or concentrated detergent, or high autoclave temperature, could have adversely impacted the sturdiness of the connector when external forces were applied.In addition, if the lma proseal is sterilized together with lubricated medical instruments, the lubricant will accelerate deterioration of the connector.

Event Description

Customer complaint alleges "prior to use noticed connector absent.Sheared off." usage of the device at the time of the reported event is unclear.There was no report of patient harm.

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• 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: 6598307
• MDR Text Key: 76243748
• Report Number: 9681900-2017-00025
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 15140
• Device Lot Number: 8VRAT9PY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1