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

Catalog Number	21-7105-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the affected extension was not returned and therefore analysis was unable to be performed.As no samples nor pictures were provided by the customer, a visual inspection was unable to be performed.The device history record was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the used samples, a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.
Event or Problem Description
It was reported that the catheter was not flushing properly and looked to possibly be occluded on one side.There was unknown patient involvement.

• Brand Name: CADD EXTENSION
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19619201
• Report Number: 3012307300-2024-05515
• Device Sequence Number: 17883363
• Product Code: FPA
• UDI-Device Identifier: 10610586022715
• UDI-Public: (01)10610586022715(17)281203(10)4440928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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 Catalogue Number: 21-7105-24
• Device Lot Number: 4440928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown