MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA PREMIUM SOFT PLUS MASKS; SOFT PLUS MASKS YELLOW HOOK RING VALVE

Catalog Number 005455

Device Problem Unintended Deflation (4061)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that the breathing mask arrived deflated, requiring reinflation prior to use.The issue was discovered upon opening.No injury or intervention required.

Manufacturer Narrative

Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual inspection and functional testing was performed.Visual inspection found no issues.Functional testing observed the mask retained inflation four weeks after starting inflation testing.The sample was forwarded to the supplier for awareness of the reported issue.Should additional information be returned pertinent to the investigation a supplemental report will be filed.D4 udi number and g5 are unknown, no product information has been provided to date.

Manufacturer Narrative

Other, other text: manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual inspection and functional testing was performed.Visual inspection found no issues.Functional testing observed the mask retained inflation four weeks after starting inflation testing.The sample was forwarded to the supplier for awareness of the reported issue.Should additional information be returned pertinent to the investigation a supplemental report will be filed.D4 udi number and g5 are unknown, no product information has been provided to date.

• Brand Name: PORTEX GENERAL ANESTHESIA PREMIUM SOFT PLUS MASKS
• Type of Device: SOFT PLUS MASKS YELLOW HOOK RING VALVE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14547967
• MDR Text Key: 293351853
• Report Number: 3012307300-2022-10110
• Device Sequence Number: 1
• Product Code: CAI
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 005455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1