MAUDE Adverse Event Report: NULL BREATHING PORTEX GENERAL ANESTHESIA SODASORB CO2 A; ABSORBENT, CARBON-DIOXIDE

Device Problem Defective Component (2292)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.Catalog number is unknown.Udi information is unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted at the supplier site.A product sample was received for evaluation.Visual and functional testing were performed by the supplier.The root cause of the reported issue was found to be related to customer care.It has been determined that the damage occurs during shipments of single cartons of pre-paks from the distributors to end users.Unpalletized prepak carton shipping procedures, has been provided to smith's medical 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 this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that upon opening a new canister of sodasorb granules, the indicator color was purple.No patient injury was reported.

• Brand Name: BREATHING PORTEX GENERAL ANESTHESIA SODASORB CO2 A
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section G): NULL
• MDR Report Key: 15476184
• MDR Text Key: 306183778
• Report Number: 3012307300-2022-20205
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2022
• 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