MAUDE Adverse Event Report: NULL SODASORB CO2 ABSORBENT; ABSORBENT, CARBON-DIOXIDE

Catalog Number 008870

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

It was reported that the tops of the product are not adhered quite right.No patient injury was reported.

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.This is a supplied item; the device history record (dhr) is at the supplier.It has been determined that the damage occurred during shipments of single cartons of pre-paks from the distributors to end users.Unpalletized prepack carton shipping procedures, has been provided to the manufacturer several times over the last five years.This procedure details packaging the single packs of discs in an overpack with shipping popcorn.This will prevent damage to the pre-paks.The box the pre-packs are packaged in cartons that clearly states they are fragile.The reported issue was confirmed.The root cause of the reported issue was found to be in the shipment process.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: SODASORB CO2 ABSORBENT
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section G): NULL
• MDR Report Key: 15433821
• MDR Text Key: 306005859
• Report Number: 3012307300-2022-19349
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2022

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 Catalogue Number: 008870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 09/15/2022
• 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