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

Catalog Number 15140

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "after inserting the lma into the patient, upon connecting the proseal to the breathing circuit, the 15mm connector broke off".No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the connector on the device was broken.It was also found that there were crazed lines on the connector.The crazed lines on the surface of the connector were smooth to the touch.Upon closer observation it was noticed that there were some jagged edges (symptoms of cracks due to force) on the broken connector.The jagged edges at where the connector split appeared to be ruptured by force.A device history record (dhr) 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, or add-on washing agents such as lubricant on the device could have possible adversely impacted the sturdiness of the connector properties which could result in the connector breaking when external force is applied.Per the ifu recommendation, to process the lma proseal with a mild detergent such as enzymatic cleaning agents with autoclaving time (held time) of 10 minutes at 134degrees c.Disinfectants is not recommended as per ifu.

Event Description

Customer complaint alleges "after inserting the lma into the patient, upon connecting the proseal to the breathing circuit, the 15mm connector broke off".No patient harm reported.Patient condition reported as fine.

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8174892
• MDR Text Key: 131490081
• Report Number: 9681900-2018-00044
• 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: 12/04/2018

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: 8VRAKAU5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BREATHING CIRCUIT.; BREATHING CIRCUIT.