MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; CATHETER, CANNULA

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 is too long and not clicking into place.Cannot fasten valve on to it.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Samples were returned for evaluation.The samples were visually inspected under normal conditions of illumination according to site visual inspection procedure.They then were aligned to perform quality check as procedure, there was no variation appreciable in none of the sample groups.The length of returned samples were checked using the length gauge as procedure.One of the three decontaminated samples passed, while the other two were rejected; no discrepancies were detected on unused samples, both passed the length check.The most probable root cause is a human error occurred after cutting the cannula to the required length while dispositioning to scrap, since the calibrated measuring fixture gauge can detect a dimensional issue.

• Type of Device: CATHETER, CANNULA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 12976029
• MDR Text Key: 283672675
• Report Number: 3012307300-2021-12601
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: 4018219
• 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: 04/07/2022
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1