MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 3 (150030); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint alleges "the proseal 15mm connector broke off after connecting it to their ventilator".No patient injury or consequence reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).Lot# corrected to sn: (b)(4), catalog# corrected to 15140.The sample was returned for evaluation.A visual exam was performed and it was observed that there were blue stains and a pink mark on the cuff.It was also noticed that the airway tube was yellowish.Upon closer examination of the failure location it was found there were jagged edges on the connector.The jagged edges at where the connector split appeared to be ruptured by force.A device history record review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The use of non-compatible detergent or concentrated detergent on the lma device could have possibly adversely impacted the sturdiness of the connector, which could result in the connector breaking when external force is applied.

Event Description

Customer complaint alleges "the proseal 15mm connector broke off after connecting it to their ventilator".No patient injury or consequence reported.Patient condition reported as fine.

• Brand Name: LMA PROSEAL, REU, SIZE 3 (150030)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8041466
• MDR Text Key: 126390611
• Report Number: 9681900-2018-00039
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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: No Information
• Device Catalogue Number: 15140
• Device Lot Number: 8WSAK9S4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATOR; VENTILATOR