MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EB ROBERTSHAW LEFT 35F; TUBE, BRONCHIAL,W/ DIFFERENTIAL VENT

Catalog Number 116100350

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2016

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 still in progress.

Event Description

Customer complaint alleges that the "doctor found cuff leakage prior to use on patient during functional testing".No report of patient involvement.

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 no obvious defects were observed other than a stain found on the device.Both the clear and blue cuffs were inflated to 25 m bar with a calibrated endotest meter.It was observed that the pressure in the clear cuff dropped rapidly after inflation.No issues were detected with the blue cuff.The device was then immersed into water and air bubbles were observed coming from the clear cuff.No bubbles were seen coming from the blue cuff.The area of leakage was detected on the clear cuff and observed under magnification.A cut mark was found.The cut resembles that made by scissors.A 100% leak test is performed during the manufacturing process; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It is most likely that the defect is due to improper handling by the end user during preparation, although this could not be confirmed.Other remarks: a conclusion code could not be chosen as the complaint of cuff leaking was confirmed; however, a root cause could not be established.

Event Description

Customer complaint alleges that the "doctor found cuff leakage prior to use on patient during functional testing".No report of patient involvement.

• Brand Name: RUSCH EB ROBERTSHAW LEFT 35F
• Type of Device: TUBE, BRONCHIAL,W/ DIFFERENTIAL VENT
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6287116
• MDR Text Key: 66076247
• Report Number: 8040412-2017-00032
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 116100350
• Device Lot Number: 16FT15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1