MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7343-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(3/3 reference (b)(4) for related complaints) (documenting 1/1 leaking at the side port) per email: nurses are reporting leaking tubing on the milrinone patients.Three instances of leaking at the filter and one instance of leaking from the side port of the tubing.The cadd tubing number is 21-7343-24 and the lot# is 4232329.
Additional Manufacturer Narrative
No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

• Brand Name: CADD MEDICATION CASSETTES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14983109
• Report Number: 3012307300-2022-13248
• Device Sequence Number: 4973449
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: 15019517191820
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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: 21-7343-24
• Device Catalogue Number: 21-7343-24
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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