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

Model Number 11-1010

Device Problem Component Missing (2306)

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

Event Date 07/05/2022

Event Type  malfunction  

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 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
• 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; 7th ave. cor. 30th st.,; minneapolis, MN 55442
• MDR Report Key: 15163522
• MDR Text Key: 303936647
• Report Number: 3012307300-2022-14642
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10788942110106
• UDI-Public: 10788942110106
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K953206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/06/2022
• 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