MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC ULTRASET; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-1991
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item in question has slits in them so they leak isoflurane and are questioning if the slits are supposed to be on this item at the rubber stopper.No additional information.
Additional Manufacturer Narrative
Device evaluation: product was not returned.After reviewing the complaint files attached to (b)(4) it was determined that the device 66-1991 that the customer described is the ported elbow with the slits in the blue port.The slits reported by the customer are supposed to be where they are.This was confirmed via email on the complaint attachment file (b)(4) customer response and follow up.Per this file, it was suggested to the customer to order 66-1995 if the slotted port was not needed.No fault found, the 66-1991 is the ported elbow with the slits in the blue port.Unable to complete a dhr review without the benefit of the lot number.The cause of the reported problem could not be determined.

• Brand Name: PNEUPAC ULTRASET
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14043147
• Report Number: 3012307300-2022-05954
• Device Sequence Number: 6301743
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 66-1991
• Device Catalogue Number: 66-1991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown