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

Catalog Number	11-1020
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Event or Problem Description
It was reported that the mdi canister on the portex oxygen/aerosol ace kit could not be placed in the canister port/dispenser.
Additional Manufacturer Narrative
Two breathing portex units received.The end of the conical unit was confirmed to be distorted, which prevented user from assembling.Upon inspection of the units, it was discovered that there were markings indicating the units were compressed.The markings were noted to be on both the spherical and conical ends indicating the distortion happened after molding and welding, and it was confirmed the t distorted end of conical units would not fit in the welding jig.The customer complaint ws confirmed, however a thorough investigation of the manufacturing process could not duplicate the fault found on the samples.The process investigation and complaints do not signify the fault is trending, therefore no action will be taken at this time.

• Brand Name: PORTEX OXYGEN/AEROSOL ACE KITS
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7874380
• Report Number: 3012307300-2018-03710
• Device Sequence Number: 16621577
• Product Code: CAF
• UDI-Device Identifier: 10788942110205
• UDI-Public: 10788942110205
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K953206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: No Information
• Device Expiration Date: 08/11/2022
• Device Catalogue Number: 11-1020
• Device Lot Number: 3474226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1