MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH LARYNGOFLEX WITH VALVE; TUBE, TRACHEOSTOMY (W/WO CONN

Catalog Number 121181-000080

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the cuff did not inflate after intubating the tube into the trachea.The user extubated the tube and found that there was a hole on the cuff".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "the cuff did not inflate after intubating the tube into the trachea.The user extubated the tube and found that there was a hole on the cuff".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4), the sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports a visual examination of the returned device showed signs of contamination.No discoloration or design irregularities were found, and the graduation marks on the shaft were clearly visible.The inspection of the blue control cuff, neck plate and connector did not reveal any irregularities.The returned product was filled with air for an inflation and deflation test and checked for leakage in the water bath.A leak was found in the distal area.The review of the device history record (dhr) of lot 20381 did not show any kind of irregularities or deviations.The performed tests confirmed a leak in the cuff of the returned device.A leakage was found in the distal area.The tightness of the cuff in the usual position of the cannula was no longer given during the application of the product.However, the function of the balloon inflation system was given.During the manufacturing process, the products are checked several times for 100% tightness of the balloon system (final inspection: holding time when filled > 12 h).A manufacturing-related failure could not be identified.The complaint for leakage is confirmed; however, a root cause for the issue could not be identified.

• Brand Name: RUSCH LARYNGOFLEX WITH VALVE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONN
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• Manufacturer (Section G): TELEFLEX MEDICAL; willy-rusch-str. 4 - 10; 71394 kernen 71394 ; GM 71394
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12668747
• MDR Text Key: 280058270
• Report Number: 9610520-2021-00007
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

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 Catalogue Number: 121181-000080
• Device Lot Number: 20381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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