MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX OXYGEN/AEROSOL ACE BREATHING KITS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 11-1020

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that the boxes are missing kits.No patient injury was reported.

Manufacturer Narrative

No product has been returned.Photos were provided for investigation.Review of the two photos provided show the difference between a full box (25 piece) and a box missing parts.The gap or space available within the box appear to be the space of the five missing parts.It appears that manufacturing packed the incorrect amount of parts on the specified boxes.The investigation could not confirm the root cause of the issue.No corrective actions are planned at this time.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX OXYGEN/AEROSOL ACE BREATHING KITS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15437554
• MDR Text Key: 305345655
• Report Number: 3012307300-2022-19451
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10788942110205
• UDI-Public: 10788942110205
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K953206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11-1020
• Device Catalogue Number: 11-1020
• Device Lot Number: 3821901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1