MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DHD ACE WITH MASK KIT; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	11-1122
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three pictures were received and evaluated.The pictures provided confirm that the product inside the box is not what the label on the box specifies.The technician was unable to confirm the lot number received by the customer.Another complaint with the same issue and the same sku and lot # was generated for investigation.It is suspected that the boxes for both lots were pre-assembled and pre-labeled at about the same time.The wrong labels were applied to the shipper box.A non-conformance report (ncr) was initiated for further investigation.Operator of device and initial are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the product was mislabeled.No patient injury was reported.

• Brand Name: DHD ACE WITH MASK KIT
• 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: 15451703
• Report Number: 3012307300-2022-19711
• Device Sequence Number: 5581991
• Product Code: CAF
• UDI-Device Identifier: 10788942111226
• UDI-Public: 10788942111226
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K961973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: 04/21/2024
• Device Model Number: 11-1122
• Device Catalogue Number: 11-1122
• Device Lot Number: 3809856
• 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: 07/24/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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