MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA SODASORB CO2 ABSORBENT; ABSORBENT, CARBON-DIOXIDE

Lot Number L02A-0060

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information: udi and pma/510k are unknown.No product information has been provided to date.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 technician visually saw the damage that was provided in the complaint.The technician email pictures to the supplier to conduct investigation.Based on the supplier's observation from the pictures, the fourth picture sent with the complaint shows the pre-paks on their sides and 10 to a box.The supplier stated this was not what the packaging configuration would look like when produced at manufacture.There are 12 per box, and they are placed in the box in an upright position.The root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause from the supplier appeared to be that the pre-paks either fell or were taken out of the box, and then were replaced in the incorrect configuration.It was assumed that pre-paks were cracked and the cellophane on the outside of the pre-paks were torn in the process.No actions were taken.

Event Description

It was reported that the canisters were supposed be individually wrapped.However, when customer opened the case, the seams on the canister split, and the canisters were cracked.No damaged to the box and it was not re-taped.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA SODASORB CO2 ABSORBENT
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16592563
• MDR Text Key: 311822867
• Report Number: 3012307300-2023-02908
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: L02A-0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1