MAUDE Adverse Event Report: CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7115-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that while in use of a smiths medical cadd extension set, leaking was noted at the one-way valve.Subsequently, the nurse had to change the tubing.No patient consequences were reported.No adverse effects were reported.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12729663
• Report Number: 3012307300-2021-10525
• Device Sequence Number: 4613852
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 21-7115-24
• Device Catalogue Number: 21-7115-24
• 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: 10/05/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 87