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

Model Number 66-1991

Device Problem Leak/Splash (1354)

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

Event Date 02/03/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288792989
• Report Number: 3012307300-2022-05954
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1