MAUDE Adverse Event Report: ST PAUL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7094-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.A device history review was also conducted on the component lot numbers and no discrepancies were found.
Event or Problem Description
It was reported that leaking was noted from the tubing connection to black plastic cadd connector.No patient injury was reported.
Additional Manufacturer Narrative
Other text: additional information was received indicating there was a potential risk of contamination due to the reported issue.It was also reported that the infusion was stopped, contributing to the patient not being adequately dosed.Patient reported to have returned to clinic due to the reported issue.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One picture was attached, during the analysis conducted it could be observed a pressure plate from a product cover with a loop; however, no leak nor the source of them can be observed, thus failure mode can not be confirmed.No testing could be performed because no samples were provided to perform a thorough investigation.Root cause cannot be determined since the complaint was not confirmed due to the fact the visual inspections in pictures received and there are not sample received for a thorough investigation.No corrective action required as the complaint was not confirmed.No problems or issues were identified during this device history record review.D5 and e4 are unknown.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; general campus unit 5w; minneapolis, MN 55442
• MDR Report Key: 13869496
• Report Number: 3012307300-2022-05123
• Device Sequence Number: 5296186
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 21-7094-24
• Device Catalogue Number: 21-7094-24
• Device Lot Number: 4206344
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 04/18/2023
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/11/2022; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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