MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX DHD METERED DOSE INHALER (MDI) SPACER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	11-1010
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.
Event or Problem Description
It was reported that there were missing parts from each end.No patient injury was reported.

• Brand Name: PORTEX DHD METERED DOSE INHALER (MDI) SPACER
• 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; 7th ave. cor. 30th st.,; minneapolis, MN 55442
• MDR Report Key: 15163522
• Report Number: 3012307300-2022-14642
• Device Sequence Number: 16671595
• Product Code: CAF
• UDI-Device Identifier: 10788942110106
• UDI-Public: 10788942110106
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K953206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: 11-1010
• Device Catalogue Number: 11-1010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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