MAUDE Adverse Event Report: ST PAUL BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number BRCA80

Device Problem Product Quality Problem (1506)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the bivona inner cannula extended past the end of the tracheostomy tube.The tracheostomy tube had to be removed and replaced as a result.The reporter noted that the product problem could have (a) damaged the trachea upon insertion, and (b) the tracheostomy tube had the potential to collapse and block the end of the tube.The product fault in this incident did not cause or contribute to any patient injury, however.

Manufacturer Narrative

H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received by shm: one sample was received for evaluation in used conditions, previously decontaminated and inside a plastic bag without its original packaging.Visual inspection results: it can be seen the brca80 cannula was returned with most probably pn: 670180 bivona tracheostomy tube according its printed dimensions.No damage could be seen on the sample returned.It can be seen the inner cannula is slightly more length than the tracheostomy tube.Functional testing: the sample was tested in process gauge cal.Id 13.1868 p lacing it inside (lg-4-2-001) and using master piece gt20218 in order to detect if dimensional issue is present.Results: the cannula was rejected per calibrated gauge during a test with the process fixture as it can be seen below in picture 4 with the red number which means a reject, only when it is green is acceptable.The most probably root cause is a human error occurred after cutting the brca80 cannula to the required length while dispositioning to scrap since calibrated measuring fixture gauge can detect the returned sample cut dimensional issue.The cause of the reported problem was traced to the manufacturing process.Action taken:1) qalert 21113 "cut of length bivona cannula" was generated on 11-aug-2021 in order to make sure it is used the correct set-up per product code length and reject criteria from manufacture procedure.2) all mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented at this time.It will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11798213
• MDR Text Key: 249727025
• Report Number: 3012307300-2021-04124
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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 Expiration Date: 08/28/2023
• Device Catalogue Number: BRCA80
• Device Lot Number: 4032512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1