MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX MANUAL RESUSCITATION ACCESSORIES; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	8501
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device is unknown.No information has been provided to date.The device history record (dhr) was at the supplier.A product sample was received for evaluation.Visual and functional testing were performed.Review of changes relevant to the product and lot numbers reported determined that the absence of the product expiration date was not the result of a manufacturing related issue, but part of a change to our product's packaging.As similar products from other, non-smiths brands do not feature printed expiration dates, it was requested that the packaging of the resuscitators be modified to no longer include these dates.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that no expiration date listed.No patient injury was reported.

• Brand Name: PORTEX MANUAL RESUSCITATION ACCESSORIES
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15437286
• Report Number: 3012307300-2022-19434
• Device Sequence Number: 6005613
• Product Code: BTM
• UDI-Device Identifier: 10351688431530
• UDI-Public: 10351688431530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K014115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare 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 Model Number: 8501
• Device Catalogue Number: 8501
• Device Lot Number: 200107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• 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): Yes
• 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