MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD.; MASK, OXYGEN, NON-REBREATHING

Catalog Number 005445

Device Problem Material Deformation (2976)

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

Event Date 09/11/2019

Event Type  malfunction  

Event Description

It was reported that smashed masks were received.No patient injury was reported.

Manufacturer Narrative

Brand name, udi, operator of device, and 510(k) are unknown; no additional information was received.The product was not returned for evaluation.This is a supplied item and the device history record (dhr) is at the supplier.No further information has been made available to date.Should additional information be returned pertinent to the investigation, a supplemental report will be filed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Type of Device: MASK, OXYGEN, NON-REBREATHING
• 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: 15280197
• MDR Text Key: 305056858
• Report Number: 3012307300-2022-15956
• Device Sequence Number: 1
• Product Code: KGB
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 005445
• Device Lot Number: 1712011A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1