MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI; OXIMETER

Model Number WW1096OUS

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

It was reported that the customer received already expired product in a new shipment.

Manufacturer Narrative

This remediation 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 shelf life of this product is 10 years from the date of manufacturing as always specified on the pick slip going out with the product from distribution center.Therefore, the expiration date labeled on the box was misleading and not actually referring to the life of the item inside the box.It was intended to informing the customer of next date the enclosed battery pack must be charged to stay alive if in storage more than a year which is always one (1) year from the last charge date on the battery storage label next to it.In conclusion, the product shipped to the customer has not expired and is not expiring, nor pose any safety or health hazard to patients.The issue is purely a process failure due to incorrect labeling /symbol chosen to reference battery recharging date which needed to be addressed added to a lapse in inventory control.As a result, non conformance has been raised for further investigation and process review.

• Brand Name: BCI
• Type of Device: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12492025
• MDR Text Key: 272109301
• Report Number: 3012307300-2021-09443
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WW1096OUS
• Device Lot Number: 4034329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1