MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60SP045

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Abnormal Blood Gases (1034); Bacterial Infection (1735); Cyanosis (1798); Respiratory Distress (2045); Low Oxygen Saturation (2477); Blood Loss (2597)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that a nurse was unable to remove the introducer while inserting a portex bivona uncuffed neonatal and pediatric flextend plus silicone tracheostomy tube during an emergency tracheostomy tube change.The nurse had to remove the tube from the patient to remove the introducer, and then inserted the tube back into the patient without the introducer.The tracheostomy tube had been used and cleaned at least once.The product issue led to severe respiratory distress and the patient received respiratory support using an ambu-bag and ayres t-piece bagging circuit for a period of time post-incident.The patient's oxygen saturation dipped significantly and caused cyanosis.Attempts were made to cannulate the patient but lost cannula due to difficulty securing the cannula; three more attempts were made to cannulate but had failed.The capillary refill time was less than 2 seconds and so no further attempts were made.Capillary gas was obtained and the reporter recalled a co2 of approximately 11kpa.Blood was evident in the tracheostomy secretions post-tracheostomy change.A peripheral blood culture was positive for staphylococcus epidermidis.The facility inspected the introducer and noted that the sheath had dislodged and moved forward, causing the introducer to become lodged in the tube.It was reported that the patient fully recovered and the event was considered resolved.

Manufacturer Narrative

One photo was returned for evaluation.Photographic inspection found the obturator protector over the tip, when it should be between the tip and the base.One device was returned for evaluation.Visual inspection of the device found the obturator protector over the tip as in the photograph.It was observed that the angle of the wire was different.Dimensional inspection of the device found the angle out of specification.Functional testing involved use and simulated use testing and found that the device was stuck on the connector and became stuck on the shaft.A review of the testing and inspection documents was found to be adequate and correct.A review of a manufacturing process for a similar part and found to be performed as expected.Based on the evidence, the root cause was unable to be determined.It was concluded that the root cause was unrelated to an issue at the manufacturing site.

• Brand Name: PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6012297
• MDR Text Key: 56909770
• Report Number: 3012307300-2016-00006
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 60SP045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: NIPPY JUNIOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 18 MO
• Patient Weight: 8