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

Model Number 21-7363-24

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical tubing was implicated in causing purging speed differences.Additionally, more then 10ml of tubing was needed instead of 8ml.There were no reported adverse events.

Manufacturer Narrative

Other, other text: device evaluation- the device was returned for evaluation.The device was given.

Event Description

Additional information received: patient information added.

Manufacturer Narrative

Other, other text: device evaluation- one device sample was returned for evaluation.The examination of the device showed the device was missing the blue clip: this is required to remain until infusion is started.The device was given functional testing with a syringe to check for occlusions but not attached to a pump for testing.The device was found to allow fluid to pass through with no occlusions or delivery problems.Because of how the device was stored (missing clip) the full testing with pump could not be conducted.

Manufacturer Narrative

Device evaluation- one device sample was returned for evaluation.The examination of the device showed the device was missing the blue clip: this is required to remain until infusion is started.The device was given functional testing with a syringe to check for occlusions but not attached to a pump for testing.The device was found to allow fluid to pass through with no occlusions or delivery problems.Because of how the device was stored (missing clip) the full testing with pump could not be conducted., corrected data: see section h10 for device evaluation information.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11120653
• MDR Text Key: 225256340
• Report Number: 3012307300-2021-00065
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161960
• UDI-Public: 15019517161960
• Combination Product (y/n): N
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/06/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 21-7363-24
• Device Lot Number: 4019453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 02/26/2021; 03/30/2021; 03/30/2021
• Supplement Dates FDA Received: 02/19/2021; 03/27/2021; 03/30/2021; 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 65