MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA PREMIUM PLUS MASKS; MASK, BREATHING

Catalog Number 15255

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Month and year of event have been provided, day is unknown.Udi number is unknown, no information has been provided to date.510k is blank device is exempt.One (1) box of 50 each was returned.There were 50 individually packaged masks in the box.A visual inspection showed there was a difference between the label on the individual package and the label on the outer box.The reported complaint was confirmed.A root cause suggested that the labels on the box and individual packaging occurred after shipment from the manufacturing facility.The manufacturing distribution site workers take out the individual packaging from the case shipped from the supplier, attaches the japanese label printed on site to the individual package and case, and then returns the individual packaging to the original case and seals it.A device history record (dhr) review found no discrepancies or anomalies during the manufacturing of the reported lot number.The manufacturing will record this event in the database to monitor future occurrence status.If the occurrence of this issue increases significantly, additional corrective actions will be taken.

Event Description

It was reported that during the pre-use check, the customer noticed the product part number was a 15245, while its package said it was a 15255.No patient injury or clinical affects was reported.No additional information is available for this complaint.

• Brand Name: PORTEX GENERAL ANESTHESIA PREMIUM PLUS MASKS
• Type of Device: MASK, BREATHING
• 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: 16589242
• MDR Text Key: 311742554
• Report Number: 3012307300-2023-02868
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• 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 Catalogue Number: 15255
• Device Lot Number: 220606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1