MAUDE Adverse Event Report: COOK INC VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE; BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The international customer reported that the size 7 versatube¿ tapered tracheostomy tube leaked at the cuff.The cuff seal was reportedly maintained at 20 cm h2o.The leaking cuff ruptured upon the removal of the device.The patient required a bronchoscope, as well as the insertion of a new versatube.The customer confirmed that the device was not kept, and is therefore unavailable for return and evaluation.

Event Description

It was initially reported the patient required a bronchoscopy, however, the patient required replacement of the versa-tube (not under bronchoscopy), with no adverse effects to the patient.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control of the returned device was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed.However, a document-based investigation was performed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.The device was not returned however photographs of the reported issue were provided.Visual examination of the returned photographs confirmed the complaint.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.With the information available the cause of this issue cannot be determined.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE
• Type of Device: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7314159
• MDR Text Key: 101527023
• Report Number: 1820334-2018-00484
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K100283
• 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: 03/05/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-VT-7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 70