MAUDE Adverse Event Report: ST PAUL BIVONA INNER CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULM

Model Number BRCA70

Device Problem Positioning Problem (3009)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that the inner cannula ona smiths medical trach tube is too long and not clicking into place.Cannot fasten valve on to it.No adverse patient effects were reported.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source is manufacturing as the most probable root cause is a human error occurred after cutting the brca70 cannula to the required length while dispositioning to scrap since calibrated measuring fixture gauge can detect the returned sample cut dimensional issue.Dhr review was done, no issues related to the original complaint were found.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The returned samples were visually inspected and normal conditions of illumination was found according to site visual inspection procedure.The length of returned samples were check using the length gauge and one of the three decontaminated samples pass, while the other 2 were rejected.No discrepancies were detected on unused samples and both passed the length check.The most probably root cause is a human error occurred after cutting the cannula to the required length while dispositioning to scrap since calibrated measuring fixture gauge can detect the returned sample cut dimensional issue.In order to address the cause that is within manufacture's responsibility, an awareness complaint notification to the production personnel was conducted by quality engineer for the defect reported by the customer.No problems or issues were identified during this device history record review.D4: udi information is unknown.G5: premarket (510k) number is unknown.Updated h6 and h10.

• Brand Name: BIVONA INNER CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULM
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 12978116
• MDR Text Key: 282099203
• Report Number: 3012307300-2021-12610
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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 Model Number: BRCA70
• Device Catalogue Number: BRCA70
• Device Lot Number: 4107002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 04/08/2022; 03/03/2023
• Supplement Dates FDA Received: 05/06/2022; 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1