MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH AGT TUBE MURPHY NASAL STR 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number 111781-75R

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "the cuff inflated with air during a pretest before use.However, it did not deflate".No patient involvement reported.

Event Description

It was reported that "the cuff inflated with air during a pretest before use.However, it did not deflate".No patient involvement reported.

Manufacturer Narrative

(b)(4) the actual device sample was received for investigation.A visual inspection was conducted and no defects were observed.Functional testing was performed and the cuff was inflated to 25mbar using calibrated endotest.There were no issues with inflation; however, it was noticed that deflation happened slower than normal.A color water test was then conducted on the complaint device to determine the area of blockage.It was discovered that the red dye flow was constricted inside the lumen.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, ther complaint is confirmed.A non-conformance was opened to address this issue.

• Brand Name: RUSCH AGT TUBE MURPHY NASAL STR 7.5
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11641499
• MDR Text Key: 244653209
• Report Number: 8040412-2021-00095
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 111781-75R
• Device Lot Number: 19ET58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1