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

Model Number	11-1020
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the boxes are missing kits.No patient injury was reported.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-19451
• Device Sequence Number: 14953816
• Product Code: CAF
• UDI-Device Identifier: 10788942110205
• UDI-Public: 10788942110205
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K953206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/09/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown