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

Model Number G54914

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant products : cook ciaglia blue rhino g2 c-ptis-350-hc-g kit and olympus bronchoscope.(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

It was reported a versatube¿ tapered tracheostomy tube was found to have an air leak on the distal point of the pilot tube after it was inserted into the patient (see associated medwatch 1820334-2018-00935).A second like device was used, (this medwatch 1820334-2018-00936) and the same issue was observed.The procedure was completed using a third device.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Investigation - evaluation: a review of the functional test, complaint history, device history record, review of drawings, review of manufacturing, review of quality control, review of specifications, and visual inspection of the returned device was conducted during the investigation.Clinical assessment: the pilot tube is used to inflate or deflate the cuff and stays outside of the body.A leaking pilot tube would prevent the cuff from remaining inflated.An underinflated cuff could cause aspiration of subglottic secretions causing lung infections and resulting in severe harm.At this time, the clinical assessment cannot eliminate any possible causes for this event such as product handling, device preparation, securing of device, patient mobility, device failure, or manufacturing related causes.The device was returned for evaluation.A functional test was performed and no leaks were noted in the device.However a video recording was provided that proves the occurrence.A document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.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.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed this complaint to be the only one associated with complaint lot number 8326398.Ifu states: warnings: cuff pressures should be monitored and adjusted routinely, and should never exceed 25mm hg.Over-inflation of the cuff may inhibit ventilation and may result in permanent damage to the trachea.Underinflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.During tube preparation, ¿test the cuff and inflation system for leakage.¿ ¿simple precautions in handling of this tube during insertion and while in place will facilitate proper function and minimize tears and breaks in the inflation system.Avoid pulling or manipulation of the inflation line, as it is designed to conduct and hold air as part of the cuff inflation system.It is recommended that the inflation line be maintained in a position allowing for patient mobility without placing tension on the line-to-cannula junction.¿ based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the quality engineering risk assessment no further action is required.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Other relevant history: respiratory distress/pathology, was ventilated.The customer confirmed that the second trach tube which was employed did come into contact with the patient.The procedure was then successfully completed with the third trach tube which was employed.Corrected data: concomitant medical products: olympus qf190 bronchoscope only.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

• 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: 7425825
• MDR Text Key: 105520807
• Report Number: 1820334-2018-00936
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10827002549149
• UDI-Public: (01)10827002549149(17)200803(10)8115427
• 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,Followup
• Report Date: 06/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: G54914
• Device Catalogue Number: C-VT-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 06/01/2018
• Supplement Dates FDA Received: 05/14/2018; 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 50