MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL REU INTRODUCER (3, 4 & 5); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 151030

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the rubber on the end of the proseal introducer has become detached from the metal framework".The reported issue was found in preparation for use.No patient harm reported.

Manufacturer Narrative

(b)(4).Corrected data: section d.1.Brand name corrected to lma proseal reu introducer (3,4,5).Section d.4.Catalog# corrected to 151030.The sample was returned for evaluation.The manufacturer reports a visual exam was performed and it was observed that the blue silicone material was damaged and was detached from the metal handle.Upon closer observation it was noticed there were scratches across the stainless steel made introducer body.It was also found that the bond of the insert-molded silicone strip was damaged.Based on the investigation performed the reported complaint was confirmed.The manufacturer states that scratches/damage on the bond of the insert-molded silicone strip will adversely impact the bonding of the silicone strip on the metal made proseal introducer and with add on pushing force at the silicone tip, the properties of the bond will be further damaged causing failure of the product.The device is reusable and will be worn out depending on usage volume and handling methods.

Event Description

Customer complaint alleges "the rubber on the end of the proseal introducer has become detached from the metal framework".The reported issue was found in preparation for use.No patient harm reported.

• Brand Name: LMA PROSEAL REU INTRODUCER (3, 4 & 5)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9538083
• MDR Text Key: 177666989
• Report Number: 9681900-2020-00001
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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: 151030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.