MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60SP040

Device Problem Connection Problem (2900)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/30/2018

Event Type  Injury  

Event Description

It was reported by the patient's parent that on (b)(6) 2018, the bivona tracheostomy tube separated from the flange and appeared to have disappeared in the stoma.The patient experienced cough and noisy breathing as a result.The parent brought the child to the er.The child was then transferred to a (b)(6) for bronchoscopy and removal of the foreign body under anesthesia.The patient was later discharged from the hospital.

Manufacturer Narrative

Three pictures of the samples were returned for evaluation.Upon visual inspection, the shaft was noted to be damaged with cuts and splits provoking an exposed wire around the shaft.Additionally, the shaft wasn't attached to the neck flange, without residue of any adhesive.A review of the manufacturing process to verify that there are no situations or practices that could create the event as described.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.In attempt to reproduce the failure mode, units were taken from engineering samples.15 samples were pulled from the lower part with force in order to see if the complaint could be reproduced.It was seen that in all samples the shafts were detached from the neckstrap, the whole adhesive stayed attached to the shaft and the shafts didn't present any damage.The reported customer complaint was not verified.

Manufacturer Narrative

Three pictures of one of the bivona tracheostomy tubes was received.In the pictures it was observed that the shaft was damaged and was without the neck flange.Another bivona tracheostomy tube was received without its original packaging.The sample was visually inspected at 12" under normal conditions of illumination in order to detect any damage on the part.During the visual inspection, it was seen that shaft was damaged with cuts and splits provoking an exposed wire around the shaft, and the shaft was not attached to the neck flange.The device history record was reviewed and showed that the devices met all manufacturing specifications for products released for distribution.No issues were identified that would have impacted this event.In attempt to reproduce the failure mode, units were taken from engineering samples.Fifteen samples were pulled from the lower part with force in order to see if the complaint could be reproduced.It was seen that in all samples, the shafts were detached from the neckstrap, the whole adhesive stayed attached to the shaft and the shafts did not present any damage.Additional units were taken from engineering samples.Another fifteen samples were pulled from the upper part with force, it was seen that three were detached from the neckstrap but the whole adhesive stayed attached to the shaft, and 12 samples were broken from the shaft, without adhesive and the wire was seen stretched.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause was that the damage occurred after the product left the manufacturing facility.As a preventive action manufacturing personnel was notified by the area trainer on 08/jun/2018, as awareness of the failure mode reported by the customer.Lastly, additional information pertaining to the post-operative report was requested but not received.This information was requested from the patient's mother to better assist with the assessment of the alleged complaint.It was noted that "mom is considering if she will allow me to release the record at this time.".

• Brand Name: PORTEX BIVONA® NEONATAL AND PEDIATRIC 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 MEDICAL ASD, INC.; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7557775
• MDR Text Key: 109688249
• Report Number: 3012307300-2018-01831
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 11/13/2018
• Supplement Dates FDA Received: 07/16/2018; 12/12/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 18